Recruiting NCT06697197
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986482, Nivolumab and rHuPH20, Nivolumab/relatlimab/rHuPH20, Bevacizumab.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Denmark, France, Greece +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors
Overview
The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
Interventions
- Drug BMS-986482
Specified dose on specified days - Drug Nivolumab and rHuPH20
Specified dose on specified days - Drug Nivolumab/relatlimab/rHuPH20
Specified dose on specified days - Drug Bevacizumab
Specified dose on specified days
Primary outcome measures
- Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) [Time frame: Up to 135 days post last treatment visit]
- Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0 [Time frame: Up to 135 days post last treatment visit]
- Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0 [Time frame: Up to Day 28]
- Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0 [Time frame: Up to 135 days post last treatment visit]
- Number of deaths as assessed by NCI-CTCAE v5.0 [Time frame: Through study completion (Up to 4 years)]
Secondary outcome measures (4)
- Concentration at the end of infusion (Cmax) [Time frame: Up to 135 days post last treatment visit]
- Time of maximum observed concentration (Tmax) [Time frame: Up to 135 days post last treatment visit]
- Area under the concentration-time curve in one dosing interval (AUC(TAU)) [Time frame: Up to 135 days post last treatment visit]
- Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by Investigator [Time frame: Up to 135 days post last treatment visit]
Eligibility criteria
Inclusion criteria
- All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
Exclusion criteria
- History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
- Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- University of California, Irvine (UCI) Health - UC Irvine Medical Center — Irvine
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles
- Local Institution - 0008 — Aurora
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
- Northwell Health/ RJ Zuckerberg Cancer Center — Lake Success
- Levine Cancer Institute — Charlotte
- Fred Hutchinson Cancer Center — Seattle
Spain · 3 centers
- Hospital Universitari Vall d'Hebron — Barcelona
- Clinica Universidad de Navarra — Pamplona
- Hospital Universitario HM Sanchinarro — Madrid
France · 2 centers
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
- Gustave Roussy — Villejuif
Greece · 2 centers
- General Hospital of Athens "Laiko" — Athens
- Papageorgiou General Hospital of Thessaloniki — Thessaloniki
Italy · 2 centers
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
- Istituto Clinico Humanitas — Rozzano
Netherlands · 2 centers
- Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) — Amsterdam
- Erasmus Medisch Centrum — Rotterdam
Belgium · 1 center
- UZ Gent — Ghent
Denmark · 1 center
- Rigshospitalet — Copenhagen
Sweden · 1 center
- Karolinska Universitetssjukhuset Solna — Solna
Identifiers
NCT: NCT06697197 · CA236-0001 · 2024-516602-28 · U1111-1309-0886