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NCT05625399 (nivolumab in melanoma): BVCT ex-ante prediction vs. reported outcome

On 19 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial partial failure for this trial. The 3 Aug 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05625399
Acronym
RELATIVITY-127
Drug Name
nivolumab
Drug MoA
Subcutaneous anti-PD1 inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
melanoma
Human Patients
579
Sponsor
Bristol Myers Squibb
Phase
Phase 3

Prediction of , index 1933

Prospective Prediction
Prediction Index
1933
Prediction Date
Commercial Prediction
partial FAILURE (commercially maybe insufficient clinical benefit in ORR/PFS/OS at least slightly inferior to IV formulation)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS/OS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
530 days in advance
Readout Data Interpretation
SC nivolumab + relatlimab achieved 43% ORR and 12.65 months PFS, both of which are slightly inferior compared with IV nivolumab + relatlimab that achieved 51% ORR and 14.98 months PFS
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma
Phase
Phase 3
Status
Active not recruiting
Enrollment
579
Lead sponsor
Bristol-Myers Squibb
Conditions
Melanoma
Interventions
DRUG: Nivolumab + Relatlimab; DRUG: rHuPH20
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-03-06
Primary completion
2025-08-04
Completion
2027-11-18
Results first posted
2026-08-26
Primary outcomes
  • Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
  • Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
  • Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))
  • Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale (Pre-dose (Day 1 to Day 28))

NCT05625399 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials