Drug Combination for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Immunosuppressants, others

Disqualifiers: Autoimmune, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs to control advanced or spreading colorectal cancer that is microsatellite stable (MSS-CRC), indicating a specific genetic trait in the cancer cells. The study includes a mix of medications: bevacizumab, BMS-986340 (an experimental treatment), nivolumab, and a combination of trifluridine and tipiracil. The trial seeks participants diagnosed with colorectal cancer that has spread or cannot be surgically removed and who have not responded to standard treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had any anticancer therapy within the past 2 weeks before enrollment, and certain medications like systemic corticosteroids or immunosuppressive therapy must be stopped 7 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of trifluridine/tipiracil and bevacizumab is generally well-tolerated. One study found that this combination improved survival rates in patients, indicating it is a safe option. However, less information is available about the effects of combining BMS-986340 and nivolumab with these drugs. As the trial is in Phase 2, researchers are still gathering safety data. This phase typically indicates that the treatment has undergone previous testing, but more data is needed to confirm its safety for a broader population. Prospective participants should understand that this trial phase is crucial for ensuring the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this colorectal cancer treatment because it combines several powerful drugs in a novel way. This combination includes BMS-986340, a new immunotherapy agent, and nivolumab, which helps the immune system better identify and attack cancer cells. Trifluridine and tipiracil, along with bevacizumab, work together to inhibit tumor growth and cut off the blood supply that feeds the cancer. Unlike the current standard of care, which often involves chemotherapy alone, this multi-faceted approach could offer a more comprehensive attack on the cancer, potentially improving outcomes for patients.

What evidence suggests that this trial's drug combination could be effective for colorectal cancer?

This trial will evaluate a combination of drugs for colorectal cancer. Studies have shown that trifluridine/tipiracil combined with bevacizumab shows promise for patients with metastatic colorectal cancer, improving outcomes for those who have already tried other treatments. In this trial, participants will receive this combination along with Nivolumab, which enhances the immune system's ability to fight cancer, and BMS-986340, a new drug being tested for its potential to enhance these effects. Together, these drugs might help manage advanced colorectal cancer more effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Madhulika Eluri, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced or metastatic microsatellite-stable colorectal cancer (MSS-CRC) who haven't responded to standard treatments. Specific eligibility criteria are not provided, but typically participants need to meet certain health standards and may be required to have a particular type of tumor.

Inclusion Criteria

Participants must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,500/mcL, Hemoglobin ≥9 g/dL, platelets ≥100,000/mcL, AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN (unless if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5 x ULN), Total serum bilirubin <1.5 x upper limit of normal (ULN) (unless Gilbert disease confirmed), Creatinine ≤ institutional ULN

Participants must have measurable disease as defined by RECIST version 1.1

I had hepatitis C but have been treated and cured.

Exclusion Criteria

Participants with uncontrolled intercurrent illness

I do not have severe heart problems like unstable angina or advanced heart failure.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab

12 months

Every 4 weeks (Q4W)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• BMS-986340
• Nivolumab
• Trifluridine + Tipiracil

Trial Overview The study is testing the effectiveness of combining BMS-986340 with nivolumab, trifluridine/tipiracil, and bevacizumab in controlling MSS-CRC. It's a phase 2 trial where all participants receive this combination therapy.

How Is the Trial Designed?

Group I: SLI/Exp Experimental Treatment 4 Interventions

SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Strategic Alliance

Collaborator

Trials

2

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07011550

NCT07011550 | Phase 2, Single-arm Trial of BMS-986340 ... Primary Objectives. To determine the safety of the combination of BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab.

2. patlynk.com patlynk.com/trial/NCT07011550

BMS-986340, Nivolumab, Trifluridine/Tipiracil and ... This study could offer valuable insights into improving treatment for this type of colorectal cancer and might lead to better outcomes for patients in the ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT510654

Real-world clinical outcomes of patients with metastatic ... Real-world clinical outcomes of patients with metastatic colorectal cancer (mCRC) treated with trifluridine-tipiracil + bevacizumab by performance status.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11272516/

Innovations in colorectal cancer treatment: trifluridine and ... New research suggests the combination of trifluridine and tipiracil with bevacizumab as a promising alternative for patients who have previously been treated ...

5. withpower.com withpower.com/trial/phase-2-nivolumab-10-2025-2f4e9

Drug Combination for Colorectal Cancer Trial Overview The study is testing the effectiveness of combining BMS-986340 with nivolumab, trifluridine/tipiracil, and bevacizumab in controlling MSS-CRC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11484657/

Efficacy and safety of trifluridine/tipiracil plus bevacizumab ... Combined therapy exhibited significant improvements in overall survival (OS) hazard ratios (HR 0.60; 95% CI 0.49–0.72; p < 0.01) and progression ...

7. trial.medpath.com trial.medpath.com/clinical-trial/e7c525993f1c78a1/nct07011550-bms-986340-nivolumab-trifluridine-tipiracil-bevacizumab-colorectal-cancer

Phase 2, Single-arm Trial of BMS-986340 in Association With ... Primary Objectives * To determine the safety of the combination of BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab.