TG4001 + Avelumab for Cancer

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Transgene

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The study will consist of two parts : In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation. In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies. In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies. In both phases, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.

Research Team

Eligibility Criteria

Adults with HPV-16 positive cancers (cervical, vulvar, vaginal, penile, anal) that can't be removed by surgery or cured with radiotherapy. Participants must have a life expectancy of at least 3 months and should not have had more than one prior systemic treatment for their cancer. They need to have measurable disease by CT scan and good organ function. Women must test negative for pregnancy and all participants must use effective contraception.

Inclusion Criteria

My condition cannot be cured with surgery or radiotherapy, and it's getting worse.

I cannot receive platinum-based cancer treatment.

Negative blood pregnancy test at screening for women of childbearing potential

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Exclusion Criteria

I do not have serious heart or blood vessel problems.

Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC), any history of anaphylaxis, or uncontrolled asthma

I have previously received immunotherapy for cancer.

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Treatment Details

Interventions

Avelumab (Monoclonal Antibodies)
TG4001 (Virus Therapy)

Trial OverviewThe trial is testing TG4001 in combination with Avelumab against Avelumab alone in patients with advanced HPV-16 related cancers. Phase Ib focuses on safety at different doses without dose escalation within patients. Phase II evaluates efficacy and safety in a single-arm study first, then compares the combo to Avelumab alone in a randomized controlled setting.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: TG4001/AvelumabExperimental Treatment2 Interventions

Group II: AvelumabExperimental Treatment1 Intervention

Applicable for Phase II part 2.

Avelumab is already approved in Japan for the following indications: