CTIS2024-515119-23-00
Recruiting
Phase 1
A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies - TG4001.12
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Transgene
- Enrollment
- 142
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female or male patients, aged at least 18 years (no upper limit of age), Negative blood pregnancy test at screening for women of childbearing potential, Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration, ECOG PS 0 or 1, Life expectancy of at least 3 months, Phase Ib and Phase II part 1: Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV\-16 \+ cancer (cervical, vulvar, vaginal, penile, anal cancers and oropharyngeal squamous cell carcinoma of head and neck); Phase II part 2: Patients with HPV\-16\+ cancers including cervical, vulvar, vaginal, penile, and anal cancer, Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression, Prior therapy: Phase Ib and Phase II part 1: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum\-based therapy, either as part of definitive chemoradiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum\-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo\-radiation therapy for localized disease. Phase II part 2: \- No more than one prior systemic treatment for recurrent /metastatic disease \- Prior treatment for recurrent or metastatic disease is not required for: o Patients with recurrence/progression within 6 months after completion of prior multimodal therapy for localized or locally advanced disease oPatients who are unsuitable for platinum\-based therapy oPatients who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease, For patients with hepatic metastases \- no more than 3 hepatic lesions in total (target and non\-target lesions) \- maximum size of hepatic target disease \= 30 mm according to RECIST 1\.1, At least one measurable lesion by CT scan according to RECIST 1\.1\., Adequate hematological, hepatic and renal function
Exclusion Criteria
- •Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co\-regulatory proteins (immune checkpoints), Patients with history of interstitial lung disease, Patients 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, Significant chronic or acute infections including SARS\-CoV\-2 (COVID19\) PCR positive testing, 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 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%), Patients 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 patients 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, Patients 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, Patients 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, Patient with any organ transplantation, including allogeneic stem cell transplantation, Known severe hypersensitivity reactions to monoclonal antibodies (Grade \= 3 NCI\-CTC V4\.03\), 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
Outcomes
Primary Outcomes
Not specified
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