Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers (NCT03260023) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
United States, France, Spain143 participantsStarted 2017-09-01
Plain-language summary
The study will consist of two parts :
In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 participants at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-participant 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 participants 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 participants with HPV-16 positive advanced malignancies.
In both phases, evaluation of tumor response will be done locally according to RECIST 1.1.
All participants will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female or male participants, aged at least 18 years (no upper limit of age)
* ECOG PS 0 or 1
* Life expectancy of at least 3 months
* Participants with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer: cervical, vulvar, vaginal, penile and anal.
* Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression
* Prior therapy:
* No more than one prior systemic treatment for recurrent /metastatic disease
* Prior treatment for recurrent or metastatic disease is not required for:
* Participants with recurrence/progression within 6 months after completion of prior multimodal therapy for localized or locally advanced disease
* Participants who are unsuitable for platinum-based therapy
* Participants who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease
* Limited hepatic disease for participants with liver metastases at baseline
* Availability of tumor tissue from biopsy
* At least one measurable lesion by CT scan according to RECIST 1.1.
* Adequate hematological, hepatic and renal function
* Negative blood pregnancy test at screening for women of childbearing potential
* Highly effective contraception for both male and female participants if the risk of conception exists during the study period and for 3 months after the last study treatment administration
Exclusion Criteria:
* Prior expos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ib: To Evaluate the Safety and Tolerability of the Combination of TG4001 Plus Avelumab in Participants With Recurrent or Metastatic HPV-16 Positive Advanced Malignancies
Timeframe: From Day 1 to Day 28
2
Phase II Part 1: Overall Response Rate (ORR) by RECIST 1.1
Timeframe: From treatment start, every 6 weeks for the first 9 months, then every 12 weeks up to 2 years.
3
Phase II Part 2 Cohort A: Progression Free Survival (PFS) by RECIST 1.1
Timeframe: From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.
4
Progression Free Survival (PFS) Phase II Part 2 Cohort A by Stratification
Timeframe: From randomization: Every 6 weeks for the first 9 months, then every 12 weeks through study completion, for an average of 1 year.