Nivolumab + Chemotherapy for Anal Cancer

Recruiting at 659 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding nivolumab to standard chemotherapy is more effective for patients with metastatic anal cancer. Nivolumab helps the immune system fight cancer, while chemotherapy kills or stops cancer cells from growing. Nivolumab has shown significant effectiveness in treating metastatic squamous cell carcinoma of the anal canal.

Research Team

Cathy Eng

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

Adults with metastatic anal squamous cell carcinoma, including those HIV-positive on effective therapy or cured of hepatitis C. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and not pregnant or breastfeeding. Excluded are those with recent major surgery, interstitial lung disease, active infections requiring IV antibiotics, certain autoimmune diseases, or prior systemic chemotherapy for metastatic anal cancer.

Inclusion Criteria

All HIV+ patients should be under the care of an infectious diseases specialist. If a relationship with an infectious diseases specialist is not established, an infectious disease specialist should be consulted. Records of all viral counts and peripheral T-cell counts should be documented in order to follow these values over the course of treatment

All patients must be willing to undergo testing for HIV testing if not tested within the past 12 months

I can understand and am willing to sign the consent form, or I have someone who can do it for me.

Exclusion Criteria

I am using or willing to use effective birth control or abstain from sex as required.

I am not on high-dose steroids or other immune-weakening drugs.

I haven't used chemotherapy or trial drugs for my advanced anal cancer.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Nivolumab (Monoclonal Antibodies)
• Paclitaxel (Anti-microtubule agent)

Trial Overview This phase 3 trial is testing the effectiveness of adding nivolumab (an immunotherapy drug) to standard chemotherapy drugs carboplatin and paclitaxel in treating metastatic anal cancer. The goal is to see if this combination improves outcomes compared to chemotherapy alone.

Participant Groups

Group I: Arm B (carboplatin, paclitaxel, nivolumab) Experimental Treatment 3 Interventions

Patients receive nivolumab IV over 30 minutes on days 1 and 15 of cycle 1 and then on day 1 only of subsequent cycles, paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (carboplatin, paclitaxel) Active Control 2 Interventions

Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin IV on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+