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RecruitingLast updated: 19 September 2024

This study is seeking to determine how safe, tolerable, and what the recommended doses are of a new cancer drug (called BMS-986340) when given alone, and in combination with immunotherapy or chemotherapy, in people with advanced solid cancersA Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Clinical summary

Summary

This study has two stages: dose escalation and dose expansion.

In the dose escalation phase, there are three cohorts. In Cohort 1A, participants will receive the investigational drug (called BMS-986340) in escalating doses. In Cohort 1B, participants will receive BMS-986340 in escalating doses plus immunotherapy (called nivolumab). In Cohort 1C, participants will receive BMS-986340 in escalating doses plus chemotherapy (called docetaxel).

In the dose expansion phase, there are two cohorts. In Cohort 2A, participants will receive BMS-986340 alone. In Cohort 2B, participants will receive BMS-986340 plus nivolumab. All treatments will be administered via intravenous infusion (IV).

Conditions

This trial is treating patients with advanced solid cancers, including: cervical cancer, stomach cancer, cancer of the gastro-oesophageal junction, bowel cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, renal cell carcinoma, urothelial carcinoma, pancreatic cancer, melanoma, ovarian cancer, and triple negative breast cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Eligibility

Inclusion

  • Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Radiographically documented progressive disease on or after the most recent therapy
  • Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Exclusion

  • Women who are pregnant or breastfeeding
  • Primary central nervous system (CNS) malignancy
  • Untreated CNS metastases
  • Leptomeningeal metastases
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
  • Active, known, or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • Prior organ or tissue allograft
  • Uncontrolled or significant cardiovascular disease
  • Major surgery within 4 weeks of study drug administration
  • History of or with active interstitial lung disease or pulmonary fibrosis

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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