Status:
ACTIVE_NOT_RECRUITING
Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
Lead Sponsor:
Transgene
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Conditions:
HPV-Related Carcinoma
HPV-Related Cervical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
- Participants under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of participants with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
- Participants with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease
- Other active malignancy requiring concurrent systemic intervention
- Participants with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
- Participant with any organ transplantation, including allogeneic stem cell transplantation
- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC), any history of anaphylaxis, or uncontrolled asthma
- Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products
- Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients
- Participants with known history or any evidence of active interstitial lung disease / pneumonitis
- Participants with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment
- 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
- History of uncontrolled intercurrent illness including but not limited to:
- Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower)
- Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%)
- Uncontrolled infection
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03260023
Start Date
September 1 2017
End Date
December 1 2025
Last Update
December 2 2025
Active Locations (20)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
I.C.O. Paul Papin
Angers, France
4
CHU Besançon
Besançon, France