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No longer recruiting (closed or complete)Last updated: 1 May 2024

CA115: This study is evaluating a new drug (called BMS-986442) in combination with immunotherapy (called nivolumab), with or without chemotherapy, in people with advanced solid cancers and non-small cell lung cancerA Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

CA115

Clinical summary

Summary

Eligible participants will be allocated to one of the following experimental treatment arms.

Part A: Participants will receive BMS-986442 plus nivolumab immunotherapy

Part B1: Will recruit second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet non-small cell lung cancer patients, who will receive BMS-986442 plus nivolumab immunotherapy.

Part B2: Will recruit Post IO Gastric cancer/Gastro-oesophageal junction and Post-IO squamous cell carcinoma of the head and neck patients, who will receive BMS-986442 plus nivolumab immunotherapy.

Part C: Participants will receive BMS-986442 plus nivolumab immunotherapy and docetaxel chemotherapy

Part D: Participants will receive BMS-986442 plus nivolumab immunotherapy and carboplatin and pemetrexed chemotherapy.

Part E: Participants will receive BMS-986442 plus nivolumab immunotherapy and carboplatin and paclitaxel chemotherapy

Conditions

This trial is treating people with advanced solid cancers

Eligibility

Inclusion

  • Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion

  • Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
  • Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
  • Participants with an active, known, or suspected autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT05543629 *
  • CA115-001; 2022-501676-26; U1111-1283-1243

Trial sponsor

Bristol-Myers Squibb

Scientific Title

A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

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