Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Bmab1700 for Melanoma

This study wants to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.

Official registry: https://clinicaltrials.gov/study/NCT07476326 · Biocon Biologics UK PLC · enrollment listed as 120

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Bmab1700, or Opdivo. The registry lists allocation as randomized. This study wants to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.

They plan to enroll about 120 people at 46 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma

Interventions: Bmab1700, Opdivo

Primary outcome (registry wording): Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Complete surgical resection of melanoma must have been performed within 12 weeks before randomization
  • All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator

Public study contact (from the registry)

Dr. Gursharan Singh, MBBS; PhD Pharm Med; LLM-IP

+91 80 2808 2066

gursharan.singh@biocon.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

46 listed

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FAQ about this NCT record

Is NCT07476326 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07476326?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07476326?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary