Clinical trial for Cervical Cancer
Official title A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04895709
What this study is testing
What is BMS-986340?
This is an investigational medicine being studied to see if it can help treat advanced solid tumors, including cervical cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new drug is safe, how well people tolerate it, and what the right dose should be.
- Who it's for
- The study is looking for people with advanced solid tumors, such as lung, breast, or skin cancer.
- What's involved
- Participants will receive BMS-986340 either by itself or combined with other medicines like nivolumab, docetaxel, or Pumitamig.
- Time commitment
- The source text does not specify the total duration of the study or the number of visits required.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- 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, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting...
You likely can't join if
- 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.
See the full eligibility 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, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Clovis, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Iowa City, Iowa, United States
- Hackensack, New Jersey, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Blacktown, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Brisbane, Queensland, Australia
- Malvern, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Montreal, Quebec, Canada
- Dresden, Germany
- Essen, Germany
- Frankfurt, Germany
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Clovis, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Iowa City, Iowa, United States; Hackensack, New Jersey, United States; Portland, Oregon, United States and 32 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.