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Monoclonal Antibodies

TG4001 + Avelumab for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Transgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression

Patients who are unsuitable for platinum-based therapy

Must not have

Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention, history of myocarditis

Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks for the first 9 months, then every 12 weeks up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will have two parts: safety will be assessed in the first part in small groups of patients at increasing doses of TG4001; efficacy and safety of the combination of TG4001 and avelumab will be evaluated in the second part. Tumor response will be evaluated on local assessment using RECIST 1.1.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects include reactions similar to those from other monoclonal antibodies such as immune-related inflammation of organs, infusion reactions which may cause discomfort or allergic responses during administration, fatigue, potential blood pressure issues if pre-existing hypertension is present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I cannot receive platinum-based cancer treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is HPV-16 positive and has spread or not responded to treatment.

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I have had only one treatment for my cancer since it spread.

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My cancer came back or got worse within 6 months after finishing treatment.

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I refuse to undergo chemotherapy or standard treatments for my recurring or spreading cancer.

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I can provide a sample of my tumor tissue.

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I have a tumor that can be measured by a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart or blood vessel problems.

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I have previously received immunotherapy for cancer.

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I have had an organ or stem cell transplant.

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I am allergic to eggs, gentamycin, or similar compounds in vaccines.

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I am allergic to components in PD-L1/PD-1 treatments.

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I have or had lung inflammation not caused by an infection.

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I do not have uncontrolled high blood pressure, diabetes, or infections.

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I am currently receiving treatment for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks for the first 9 months, then every 12 weeks up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks for the first 9 months, then every 12 weeks up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for the first 9 months, then every 12 weeks up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase II part 1: Overall Response Rate (ORR) by RECIST 1.1

Phase II part 2: Progression Free Survival (PFS) by RECISIT 1.1

Phase Ib: To evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies

Secondary study objectives

Disease control rate (DCR)

Duration of overall Response (DoR)

Overall Response Rate (ORR) by using RECIST 1.1 (phase Ib, phase II part 2)

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