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RecruitingLast updated: 12 October 2023

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

  • 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.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.