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

New cancer drug BMS-986340 tested in advanced solid tumors

NCT: NCT04895709 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Bristol-Myers Squibb · Started: 2021-05-27 · Est. Completion: 2028-07-07

Plain English Summary

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors is a Phase 2 clinical trial sponsored by Bristol-Myers Squibb studying Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms. This trial tests a new drug, BMS-986340, alone or with other cancer treatments (nivolumab or docetaxel). It is for adults with advanced solid tumors that have not responded to or cannot be treated with standard therapies. Participants will receive the study drug(s) and undergo regular check-ups and tests to monitor safety and response. Alternative treatments include other chemotherapy, targeted therapies, or immunotherapy, depending on the specific cancer type. The trial aims to enroll 949 participants.

Official Summary

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with advanced solid tumors that have progressed after standard treatments. Must have a tumor biopsy available for testing and a measurable tumor. Generally healthy with good performance status (ECOG 0 or 1). Cannot have untreated brain metastases, active autoimmune disease, or be pregnant/breastfeeding. This trial is studying Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the new drug is by tracking side effects, serious adverse events, and any events that lead to stopping the drug or death, ensuring patient safety is prioritized. The specific primary outcome measures are: Incidence of adverse events (AEs) (Up to 120 weeks); Incidence of serious adverse events (SAEs) (Up to 120 weeks); Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Up to 120 weeks); Incidence of AEs leading to discontinuation (Up to 120 weeks); Incidence of AEs leading to death (Up to 120 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited effective therapies, potentially filling a gap in current treatment approaches. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, where improved treatment options are needed.

Investor Insight

This trial investigates a novel drug in combination with established treatments, signaling potential for new therapeutic options in a competitive oncology market with significant unmet needs. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 949 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific cancer types being studied and if BMS-986340 is a suitable option for you. Understand the potential side effects and how they will be managed during the trial. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria

* 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 Criteria

* 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.

Other protocol-defined inclusion/exclusion criteria apply

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04895709?

NCT04895709 is a Phase 2 INTERVENTIONAL study titled "A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 949 participants.

What conditions does NCT04895709 study?

This trial investigates treatments for Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms. The primary condition under study is Cervical Cancer.

What treatments are being tested in NCT04895709?

The interventions being studied include: BMS-986340 (DRUG), BMS-936558-01 (DRUG), Docetaxel (DRUG). Specified dose on specified days

What does Phase 2 mean for NCT04895709?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT04895709?

This trial is currently "Recruiting." It started on 2021-05-27. The estimated completion date is 2028-07-07.

Who is sponsoring NCT04895709?

NCT04895709 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04895709?

The trial aims to enroll 949 participants. The trial is currently recruiting and accepting new participants.

How is NCT04895709 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT04895709?

The primary outcome measures are: Incidence of adverse events (AEs) (Up to 120 weeks); Incidence of serious adverse events (SAEs) (Up to 120 weeks); Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Up to 120 weeks); Incidence of AEs leading to discontinuation (Up to 120 weeks); Incidence of AEs leading to death (Up to 120 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04895709 being conducted?

This trial is being conducted at 20 sites, including Clovis, California; Los Angeles, California; Newport Beach, California; Iowa City, Iowa and 16 more sites (United States, Australia, Canada).

Where can I find official information about NCT04895709?

The official record for NCT04895709 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04895709. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04895709 testing in simple terms?

This trial tests a new drug, BMS-986340, alone or with other cancer treatments (nivolumab or docetaxel). It is for adults with advanced solid tumors that have not responded to or cannot be treated with standard therapies.

Why is this trial significant?

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited effective therapies, potentially filling a gap in current treatment approaches.

What are the potential risks of participating in NCT04895709?

Common side effects may include fatigue, nausea, diarrhea, and skin rash. Serious side effects can occur, such as severe allergic reactions, lung inflammation, or kidney problems. The study drug may interact with other medications, so it's crucial to inform your doctor about all drugs you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04895709?

Ask your doctor about the specific cancer types being studied and if BMS-986340 is a suitable option for you. Understand the potential side effects and how they will be managed during the trial. Be prepared for regular clinic visits for drug administration, blood tests, and imaging scans. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04895709 signal from an investment perspective?

This trial investigates a novel drug in combination with established treatments, signaling potential for new therapeutic options in a competitive oncology market with significant unmet needs. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive the study drug(s) and undergo regular check-ups and tests to monitor safety and response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.