EUCTR2019-001358-24-PL
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- 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
- •have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to C1D1
Outcomes
Primary Outcomes
Not specified
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