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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
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

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Disease control rate (DCR)
Duration of overall Response (DoR)
Incidence of Adverse Event reported per CTCAE v4.03
+3 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Investigations
6%
Infections and infestations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Metabolism and nutrition disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: TG4001/AvelumabExperimental Treatment2 Interventions
Group II: AvelumabExperimental Treatment1 Intervention
Applicable for Phase II part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,506 Total Patients Enrolled
26 Trials studying Carcinoma
3,710 Patients Enrolled for Carcinoma
EMD Serono Research & Development Institute, Inc.Industry Sponsor
76 Previous Clinical Trials
30,710 Total Patients Enrolled
3 Trials studying Carcinoma
1,186 Patients Enrolled for Carcinoma
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,724 Total Patients Enrolled
141 Trials studying Carcinoma
72,652 Patients Enrolled for Carcinoma

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03260023 — Phase 1 & 2
Carcinoma Research Study Groups: Avelumab, TG4001/Avelumab
Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03260023 — Phase 1 & 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260023 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does TG4001 have a long research history?

"At present, 116 different clinical trials are underway to study TG4001. 10 of these studies have reached Phase 3. Many research centres in Barcelona and South dakota are running out of funding for these tests, but there are still 3691 locations with active trials."

Answered by AI

Are there still opportunities for patients to join this trial?

"That is right, the trial is still looking for patients according to the information on clinicaltrials.gov. The posting went up on 9/11/2017 and was last updated on 2/14/2022. They are hoping to enroll 150 people total at 2 locations."

Answered by AI

Is this the initial research done on this topic?

"TG4001 has had a long clinical history, with the first study occurring in 2014. Since then, it received Phase 2 drug approval after a successful initial study of 204 people. Currently, there are 116 active trials for TG4001 happening in 52 countries and over 1000 cities."

Answered by AI

How many test subjects are participating in this experiment?

"That is right, the clinicaltrials.gov website mentions that this trial is currently looking for enrollees. The listing was created on September 11th, 2017 and edited February 14th, 2022. There are 150 spots open at 2 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
2017. "Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03260023.
~12 spots leftby Dec 2024
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