TIPAPKINOGENE SOVACIVEC for HPV-16 positive recurrent or metastatic malignancies | Oropharyngeal squamous cell carcinoma (head and neck) | Cervical cancer | Vulvar cancer | Vaginal cancer | Penile cancer | Anal cancer

Inclusion criteria

• {"criterion_text":"- Female or male patients, aged at least 18 years (no upper limit of age)\n- Negative blood pregnancy test at screening for women of childbearing potential\n- 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\n- ECOG PS 0 or 1\n- Life expectancy of at least 3 months\n- 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\n- Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression\n- 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 o\tPatients who are unsuitable for platinum-based therapy o\tPatients who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease\n- 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\n- At least one measurable lesion by CT scan according to RECIST 1.1.\n- Adequate hematological, hepatic and renal function"}

Exclusion criteria

• {"criterion_text":"- Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)\n- Patients with history of interstitial lung disease\n- 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\n- Significant chronic or acute infections including SARS-CoV-2 (COVID19) PCR positive testing\n- 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\n- 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%)\n- 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\n- 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\n- Other active malignancy requiring concurrent systemic intervention\n- 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\n- Patient with any organ transplantation, including allogeneic stem cell transplantation\n- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC V4.03), any history of anaphylaxis, or uncontrolled asthma\n- Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products\n- Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients"}

Primary endpoints

• {"endpoint_text":"- Phase Ib: safety and tolerability\n- Phase II part 1: overall response rate according to RECIST 1.1\n- Phase II part 2: progression-free survival according to RECIST 1.1","definition_or_measurement_approach":"Phase Ib: evaluated as safety and tolerability (as per main objective). Phase II part 1: Overall Response Rate (ORR) assessed by RECIST 1.1. Phase II part 2: Progression-Free Survival (PFS) assessed according to RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- Phase Ib: Overall response rate by using RECIST 1.1 and overall safety profile\n- Phase Ib and phase II part 2: Overall response rate by using RECIST 1.1\n- Phase Ib and phase II part 1: Progression Free Survival (PFS)\n- Overall Survival (OS)\n- Duration of Response (DoR)\n- Overall safety profile\n- Percentage of patients with liver metastases at baseline who have disease progression at D43 (phase II part 2)","definition_or_measurement_approach":"Where specified: ORR by RECIST 1.1; PFS per RECIST 1.1; OS standard survival endpoint; DoR standard duration from response to progression; safety profile assessed overall; percentage with progression at D43 defined for patients with liver metastases at baseline (phase II part 2)."}

Spain

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

516

Number Of Sites

6

Number Of Participants

14

France

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

574

Number Of Sites

12

Number Of Participants

128

Primary sponsor

Full Name

Transgene

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Third parties

• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"6|7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Soladis Clinical Studies","duties_or_roles":"10","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Veracyte","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Active Biomarkers","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"15 (Central lab for translational research samples management and storage)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Histalim","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Eurofins Clinical Trial Supplies France","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Institut Curie","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Spain","full_name":"Apices Soluciones S.L.","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}