EUCTR2019-001358-24-ES
Active, not recruiting
Phase 1
A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination with Bempegaldesleukin (NKTR-214) with or without Talazoparib or Enzalutamide in Participants with Locally Advanced or Metastatic Solid Tumors - JAVELIN IL-2 Medley
Conditionsocally recurrent (not amenable for curative intent) or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynxmetastatic castration-resistant prostate cancer without small cell featuresMedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocally recurrent (not amenable for curative intent) or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- Sponsor
- Pfizer Inc.
- Enrollment
- 127
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •SCCHN and mCRPC
- •\- \>/\= 18 years of age and give consent
- •\- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures as specified in the protocol
- •\- Contraceptive use must meet requirements outlined in the protocol and should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •\- COG of 0 or 1
- •\- Participants must have adequate bone marrow function without hematopoietic growth factor or transfusion support within 14 days prior to and including C1D1 per protocol
- •\- Participants must have adequate liver function by C1D1 per protocol
- •\- Participants must have adequate renal function by C1D1 per protocol
- •\- All participants must provide tumor tissue as described in protocol
- •Combination A\- SCCHN
Exclusion Criteria
- •SCCHN and mCRPC
- •\- Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCT CTCAE v4\.03 Grade \=3\)
- •\- Known history of: immune\-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
- •\- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
- •\- Participants with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •\- Prior organ transplantation
- •\- Vaccination within 4 weeks prior to C1D1 and while on trial is prohibited except for administration of inactivated vaccines
- •\- Known symptomatic brain lesions requiring steroids
- •Exception: participants with previously diagnosed brain lesions are eligible if they meet all of the following criteria:
- •have newly diagnosed small brain lesions which do not require treatment
Outcomes
Primary Outcomes
Not specified
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