Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.

Name: Kaimen Rigor review — Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.
Item: Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.
Rating: 100
Author: Alpha1

Long GV, Garnett-Benson C, Dolfi S, Ascierto PA, Guo J, Tarhini AA, Chandra S, Muñoz-Couselo E, Del Vecchio M, de Melo AC, Callahan M, Gogas H, Dummer R, Schadendorf D, Koelblinger P, Quereux G, Thomas I, Yu JX, Fisher A, Wang B, Djidel P, Chouzy A, Semaan M, Chen B, Cheong AMY, Tawbi HA

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Kaimen Rigor review — 5★ (Exemplary), 0 critical, 0 high issues for “Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.

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DOI

10.1038/s41591-025-04032-8

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96b17316ba1b24afbe9320ee86be7bc7381eef823298593bae6a2d5ed90eaac5

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Issued Aug 15, 2026Engine 7.39.0

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.

Paper source

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit1 minor suggestion

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and well-reported phase 3 randomized controlled trial. The paper demonstrates strong methodological rigor across all eight dimensions, with clear randomization, blinding, power analysis, and comprehensive reporting of demographics, ethics, resources, statistics, data availability, and transparency. The only minor issues are a typo in the trial name and a few reporting enhancements that could be made.

Both reviewers independently scored all eight dimensions and agreed on every status, indicating high sampling stability. The study type is interventional (phase 3 RCT). Non-applicable sub-criteria (e.g., animal-related, cell line authentication) were excluded from scoring. The statistics verification component recomputed only 3 reported tests consistently; other statistics were not machine-verified and should not be assumed correct.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 1 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

4 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites standard-of-care adjuvant therapies and their limitations (e.g., 5-year RFS rates around 50%), and the rationale for the trial is logically derived from the RELATIVITY-047 results showing benefit in advanced melanoma. The paper acknowledges the unmet need for more efficacious adjuvant regimens. Limitations of prior research are implicitly addressed by the trial design, though not explicitly discussed as a separate section.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior work on adjuvant therapies and the rationale for testing the combination based on RELATIVITY-047 results.

Evidence

paraphrase[Introduction, paragraph 1]

“The programmed death 1 (PD-1) immune checkpoint inhibitors nivolumab and pembrolizumab, both administered as monotherapy, and the targeted therapy combination of dabrafenib plus trametinib are standard-of-care adjuvant therapy options for patients with completely resected stage III/IV melanoma. However, approximately 50% of patients have disease recurrence, with 5-year RFS rates of 50% for nivolumab, 55% for pembrolizumab and 52% for dabrafenib plus trametinib.”

paraphrase[Introduction, paragraph 2]

“Nivolumab plus relatlimab fixed-dose combination (FDC; 480-mg nivolumab plus 160-mg relatlimab intravenously every 4 weeks) was approved for treatment of advanced melanoma based on the phase 2/3 RELATIVITY-047 trial.”

absence[Introduction]

The paper does not explicitly discuss limitations of prior research.

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior work on adjuvant melanoma therapies and the rationale for testing the combination based on the RELATIVITY-047 trial.

Evidence

“However, approximately 50% of patients have disease recurrence, with 5-year RFS rates of 50% for nivolumab , 55% for pembrolizumab and 52% for dabrafenib plus trametinib .”

Introduction ¶1Find in source

Introduction ¶2Find in source

“Given the unmet need for more efficacious adjuvant regimens for completely resected melanoma, the phase 3 RELATIVITY-098 trial compared adjuvant treatment with nivolumab plus relatlimab FDC to nivolumab in patients after complete resection of stage III/IV melanoma.”

Introduction ¶2Find in source

Randomization method (permuted blocks within strata) and unit (patient) are stated. Blinding is described (double-blind). Power analysis is provided with sample size, effect size, alpha, and power. Inclusion/exclusion criteria are prespecified. Outlier handling is addressed through the ITT analysis population and safety population definitions. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and inclusion/exclusion criteria; the analysis population is defined.

Evidence

“Randomization was carried out via permutated blocks within each stratum.”

MethodsFind in source

“The sponsor, participants, investigator and site staff were blinded to the study therapy administered.”

MethodsFind in source

“An approximate sample size of 1,050 patients was planned to achieve the required 410 RFS events and show a significant difference in investigator-assessed RFS with a two-sided α of 0.05 using a stratified log-rank test with at least 90% statistical power when the average hazard ratio of nivolumab and relatlimab FDC versus nivolumab was 0.72 and an assumed cure rate of 0.52 in the nivolumab arm.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and inclusion/exclusion criteria; the analysis population is defined.

Evidence

“Randomization was carried out via permutated blocks within each stratum. The sponsor, participants, investigator and site staff were blinded to the study therapy administered.”

MethodsFind in source

Statistical analysisFind in source

“Eligible patients were at least 12 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 and stage IIIA (>1-mm tumor in lymph node), stage IIIB/C/D or stage IV (no evidence of disease) melanoma (per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (eighth edition) (AJCC-8)) completely resected <90 days from randomization.”

MethodsFind in source

Sex is reported for both arms (male/female percentages). Age is reported as median and range. Health status is captured via ECOG performance status and disease stage. Demographics include geographic region. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and disease stage; sex is reported for both sexes, so justification is not required.

Evidence

“Male | 327 (59.8) | 315 (57.7) | | Female | 220 (40.2) | 231 (42.3)”

Table 1Find in source

“Median age (range) — years | 59 (18‒89) | 59 (19‒92)”

Table 1Find in source

paraphrase[Table 1]

“ECOG performance status — no. (%) | 0 | 494 (90.3) | 498 (91.2) | 1 | 53 (9.7) | 48 (8.8)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and disease stage; sex is reported for both arms.

Evidence

“Median age (range) — years | 59 (18‒89) | 59 (19‒92) | | Sex — no. (%) | | Male | 327 (59.8) | 315 (57.7) | | Female | 220 (40.2) | 231 (42.3)”

Table 1Find in source

“Geographic region — no. (%) | | United States/Canada | 54 (9.9) | 63 (11.5) | | Australia | 67 (12.2) | 57 (10.4) | | Europe | 318 (58.1) | 319 (58.4) | | Latin America | 76 (13.9) | 72 (13.2) | | China | 32 (5.9) | 35 (6.4)”

Table 1Find in source

The methods state that the protocol was reviewed by the institutional review board or independent ethics committee for each trial site, and all patients provided written informed consent. The trial was conducted in accordance with ICH-GCP guidelines. This satisfies the requirements for human research.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are adequately reported, with a named review process and compliance with ICH-GCP.

Evidence

“The protocol and amendments for this trial (available in the ) were reviewed by the institutional review board or independent ethics committee for each trial site, and all patients provided written informed consent before enrollment.”

EthicsFind in source

“The trial was conducted in accordance with International Council for Harmonization Good Clinical Practice guidelines”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are adequately reported, with a named review process and compliance with ICH-GCP.

Evidence

EthicsFind in source

“The trial was conducted in accordance with International Council for Harmonization Good Clinical Practice guidelines”

EthicsFind in source

The drugs are named with manufacturer (Bristol Myers Squibb) and dosing regimen. The software used for data collection and analysis is identified (Medidata Classic Rave, SAS, R). Antibodies, cell lines, and mycoplasma testing are not applicable as this is a clinical trial without wet-lab assays.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (nivolumab and relatlimab) are identified with doses and regimen; software tools are identified.

Evidence

paraphrase[Methods, Trial design, treatment and endpoints]

“Patients were randomly assigned in a 1:1 ratio to receive 480 mg of nivolumab plus 160 mg of relatlimab as FDC or 480 mg of nivolumab administered via intravenous infusion every 4 weeks”

“Data collection software used was Medidata Classic Rave (version 2025). All clinical analyses were performed using SAS software (SAS Institute) and R version 4.3.1.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (nivolumab and relatlimab) are identified with doses and regimen; software tools are identified.

Evidence

paraphrase[Methods, Trial design, treatment and endpoints]

“Patients were randomly assigned in a 1:1 ratio to receive 480 mg of nivolumab plus 160 mg of relatlimab as FDC or 480 mg of nivolumab administered via intravenous infusion every 4 weeks”

“Data collection software used was Medidata Classic Rave (version 2025). All clinical analyses were performed using SAS software (SAS Institute) and R version 4.3.1.”

Statistical analysisFind in source

The primary analysis uses a two-sided log-rank test and stratified Cox model, with HR and 95% CI reported. The paper reports exact p-values (e.g., P = 0.928). Assumptions are handled by design (stratified log-rank, Cox proportional hazards). Software is identified. Data presentation includes Kaplan-Meier curves and forest plots. Mathematical plausibility checks are not applicable for large-N continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described; effect sizes with confidence intervals are reported; p-values are exact where reported.

Evidence

“RFS was compared using a two-sided log-rank test on all randomized patients; hazard ratio and confidence intervals were estimated using a stratified Cox proportional hazards model and survival curves using Kaplan–Meier methodology.”

Statistical analysisFind in source

“hazard ratio for nivolumab plus relatlimab versus nivolumab of 1.01 (95% confidence interval: 0.83–1.22; P = 0.928)”

ResultsFind in source

“hazard ratio for nivolumab plus relatlimab versus nivolumab of 1.01 (95% confidence interval: 0.83–1.22; P = 0.928)”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described; effect sizes with confidence intervals are reported; p-values are exact where reported.

Evidence

“The primary endpoint of RFS was not statistically significantly associated in the intention-to-treat population, with a hazard ratio for nivolumab plus relatlimab versus nivolumab of 1.01 (95% confidence interval: 0.83–1.22; P = 0.928)”

ResultsFind in source

Statistical analysisFind in source

The data availability statement provides a clear mechanism for requesting data through BMS and Vivli, with conditions. This is adequate for patient-level data. Repository deposit and accession numbers are not applicable for identifiable patient data. Code sharing is not applicable as no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability statement is concrete, describing a managed-access process via BMS and Vivli; code sharing is not applicable as no custom code is described.

Evidence

paraphrase[Data availability]

“Bristol Myers Squibb will honor legitimate requests for our clinical trial data from qualified researchers with a clearly defined scientific objective. ... For details, please visit Bristol Myers Squibb at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html ... The option to submit data requests as well as review criteria for data requests are available at https://vivli.org/ourmember/bristol-myers-squibb/ .”

PASSReviewer 2· 90% conf

Data availability statement is concrete, describing a managed-access process via BMS and Vivli; no code sharing is applicable.

Evidence

paraphrase[Data availability]

The trial is registered (NCT05002569). Methods are detailed enough for replication. Limitations are discussed, including the lack of CODEX analyses in RELATIVITY-098. Conclusions are proportional, noting the lack of benefit and potential reasons. Funding and competing interests are disclosed. Reporting guideline is not explicitly mentioned but the paper follows CONSORT-like flow diagram.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, methods are complete, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov identifier: NCT05002569 (https://clinicaltrials.gov/study/NCT05002569) .”

AbstractFind in source

“Although informative, these analyses have inherent limitations preventing adequate conclusions to be drawn, including that multiplex CODEX analyses were not available for the RELATIVITY-098 study.”

Discussion ¶5Find in source

“The RELATIVITY-098 trial was funded by Bristol Myers Squibb, which collected the data and analyzed the data in collaboration with the authors.”

AcknowledgementsFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are complete, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov identifier: NCT05002569 (https://clinicaltrials.gov/study/NCT05002569) .”

AbstractFind in source

DiscussionFind in source

“The RELATIVITY-098 trial was funded by Bristol Myers Squibb, which collected the data and analyzed the data in collaboration with the authors.”

AcknowledgementsFind in source

Registered (2 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 19 references by DOI: 16 verified — 3 no DOI (shown, not verified).

3 data/code links checked; 3 live.

Copyediting

1 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 1 minor suggestion below.

1 copyedit issue flagged: mostly typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (e.g., lack of explicit CONSORT statement, limited detail on randomization implementation) and the typo, but these do not undermine the validity of the findings. No erratum is warranted beyond correcting the typo.

1.
MEDIUMcopyedit
Correct the typo 'RELATVITY-098' to 'RELATIVITY-098' in the Discussion, last paragraph.
A misspelling of the trial name in a published article is a minor but visible error that should be corrected.
2.
MEDIUMreporting
Explicitly state adherence to CONSORT guidelines in the Methods or Reporting Summary.
While the paper includes a CONSORT diagram, explicitly naming the guideline strengthens reporting transparency.
3.
MEDIUMreporting
Provide a more detailed description of the randomization implementation (e.g., interactive response technology) in the Methods.
Detailing the randomization implementation enhances reproducibility and transparency.
4.
MEDIUMstatistics
Clarify the handling of missing data for the primary endpoint analysis (e.g., censoring rules) in the Statistical analysis section.
Explicitly describing censoring and missing data handling helps readers assess the robustness of the primary analysis.
5.
MEDIUMstatistics
Include a statement on whether any analyses were adjusted for multiple comparisons in the translational biomarker analyses.
The paper notes no adjustment was made; stating this explicitly avoids ambiguity about the exploratory nature of these analyses.
6.
LOWdata code
Provide the full protocol and statistical analysis plan as supplementary material or a direct link.
The protocol is referenced but not directly linked; making it available enhances transparency and reproducibility.

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Read alongside

Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial.

Read full text (PMC)

DOI

10.1038/s41591-025-04032-8

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Record fingerprint

96b17316ba1b24afbe9320ee86be7bc7381eef823298593bae6a2d5ed90eaac5

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit1 minor suggestion

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 1 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

4 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior work on adjuvant therapies and the rationale for testing the combination based on RELATIVITY-047 results.

Evidence

paraphrase[Introduction, paragraph 1]

paraphrase[Introduction, paragraph 2]

absence[Introduction]

The paper does not explicitly discuss limitations of prior research.

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior work on adjuvant melanoma therapies and the rationale for testing the combination based on the RELATIVITY-047 trial.

Evidence

“However, approximately 50% of patients have disease recurrence, with 5-year RFS rates of 50% for nivolumab , 55% for pembrolizumab and 52% for dabrafenib plus trametinib .”

Introduction ¶1Find in source

Introduction ¶2Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and inclusion/exclusion criteria; the analysis population is defined.

Evidence

“Randomization was carried out via permutated blocks within each stratum.”

MethodsFind in source

“The sponsor, participants, investigator and site staff were blinded to the study therapy administered.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and inclusion/exclusion criteria; the analysis population is defined.

Evidence

“Randomization was carried out via permutated blocks within each stratum. The sponsor, participants, investigator and site staff were blinded to the study therapy administered.”

MethodsFind in source

Statistical analysisFind in source

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and disease stage; sex is reported for both sexes, so justification is not required.

Evidence

“Male | 327 (59.8) | 315 (57.7) | | Female | 220 (40.2) | 231 (42.3)”

Table 1Find in source

“Median age (range) — years | 59 (18‒89) | 59 (19‒92)”

Table 1Find in source

paraphrase[Table 1]

“ECOG performance status — no. (%) | 0 | 494 (90.3) | 498 (91.2) | 1 | 53 (9.7) | 48 (8.8)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and disease stage; sex is reported for both arms.

Evidence

“Median age (range) — years | 59 (18‒89) | 59 (19‒92) | | Sex — no. (%) | | Male | 327 (59.8) | 315 (57.7) | | Female | 220 (40.2) | 231 (42.3)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are adequately reported, with a named review process and compliance with ICH-GCP.

Evidence

EthicsFind in source

“The trial was conducted in accordance with International Council for Harmonization Good Clinical Practice guidelines”

EthicsFind in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are adequately reported, with a named review process and compliance with ICH-GCP.

Evidence

EthicsFind in source

“The trial was conducted in accordance with International Council for Harmonization Good Clinical Practice guidelines”

EthicsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational products (nivolumab and relatlimab) are identified with doses and regimen; software tools are identified.

Evidence

paraphrase[Methods, Trial design, treatment and endpoints]

“Patients were randomly assigned in a 1:1 ratio to receive 480 mg of nivolumab plus 160 mg of relatlimab as FDC or 480 mg of nivolumab administered via intravenous infusion every 4 weeks”

“Data collection software used was Medidata Classic Rave (version 2025). All clinical analyses were performed using SAS software (SAS Institute) and R version 4.3.1.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational products (nivolumab and relatlimab) are identified with doses and regimen; software tools are identified.

Evidence

paraphrase[Methods, Trial design, treatment and endpoints]

“Patients were randomly assigned in a 1:1 ratio to receive 480 mg of nivolumab plus 160 mg of relatlimab as FDC or 480 mg of nivolumab administered via intravenous infusion every 4 weeks”

“Data collection software used was Medidata Classic Rave (version 2025). All clinical analyses were performed using SAS software (SAS Institute) and R version 4.3.1.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described; effect sizes with confidence intervals are reported; p-values are exact where reported.

Evidence

Statistical analysisFind in source

“hazard ratio for nivolumab plus relatlimab versus nivolumab of 1.01 (95% confidence interval: 0.83–1.22; P = 0.928)”

ResultsFind in source

“hazard ratio for nivolumab plus relatlimab versus nivolumab of 1.01 (95% confidence interval: 0.83–1.22; P = 0.928)”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described; effect sizes with confidence intervals are reported; p-values are exact where reported.

Evidence

ResultsFind in source

Statistical analysisFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability statement is concrete, describing a managed-access process via BMS and Vivli; code sharing is not applicable as no custom code is described.

Evidence

paraphrase[Data availability]

PASSReviewer 2· 90% conf

Data availability statement is concrete, describing a managed-access process via BMS and Vivli; no code sharing is applicable.

Evidence

paraphrase[Data availability]

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, methods are complete, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov identifier: NCT05002569 (https://clinicaltrials.gov/study/NCT05002569) .”

AbstractFind in source

Discussion ¶5Find in source

“The RELATIVITY-098 trial was funded by Bristol Myers Squibb, which collected the data and analyzed the data in collaboration with the authors.”

AcknowledgementsFind in source

PASSReviewer 2· 95% conf

The trial is registered, methods are complete, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov identifier: NCT05002569 (https://clinicaltrials.gov/study/NCT05002569) .”

AbstractFind in source

DiscussionFind in source

“The RELATIVITY-098 trial was funded by Bristol Myers Squibb, which collected the data and analyzed the data in collaboration with the authors.”

AcknowledgementsFind in source

Registered (2 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 19 references by DOI: 16 verified — 3 no DOI (shown, not verified).

3 data/code links checked; 3 live.

Copyediting

1 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 1 minor suggestion below.

1 copyedit issue flagged: mostly typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
MEDIUMcopyedit
Correct the typo 'RELATVITY-098' to 'RELATIVITY-098' in the Discussion, last paragraph.
A misspelling of the trial name in a published article is a minor but visible error that should be corrected.
2.
MEDIUMreporting
Explicitly state adherence to CONSORT guidelines in the Methods or Reporting Summary.
While the paper includes a CONSORT diagram, explicitly naming the guideline strengthens reporting transparency.
3.
MEDIUMreporting
Provide a more detailed description of the randomization implementation (e.g., interactive response technology) in the Methods.
Detailing the randomization implementation enhances reproducibility and transparency.
4.
MEDIUMstatistics
Clarify the handling of missing data for the primary endpoint analysis (e.g., censoring rules) in the Statistical analysis section.
Explicitly describing censoring and missing data handling helps readers assess the robustness of the primary analysis.
5.
MEDIUMstatistics
Include a statement on whether any analyses were adjusted for multiple comparisons in the translational biomarker analyses.
The paper notes no adjustment was made; stating this explicitly avoids ambiguity about the exploratory nature of these analyses.
6.
LOWdata code
Provide the full protocol and statistical analysis plan as supplementary material or a direct link.
The protocol is referenced but not directly linked; making it available enhances transparency and reproducibility.

Full text (56,463 chars)Analyzed: Aug 15, 2026