Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metast… (NCT04052204) | Clinical Trial Compass
TerminatedPhase 1/2
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Stopped: Study prematurely terminated as the experimental treatments evaluated in study B9991040 may not provide additional clinical benefit over current or future Standard of Care in the different therapeutic indications that this trial was to evaluate.
United States, Belgium, Poland3 participantsStarted 2019-12-30
Plain-language summary
Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be ≥ 18 years old.
* Participants with SCCHN or mCRCP.
* Participants must have histological diagnosis of solid tumors and provide tumor tissue.
* Measurable disease by RECIST v1.1 with at least 1 measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
* Adequate bone marrow, renal and liver function
* Highly effective contraceptive use by men with the ability to father a child or women of childbearing potential.
* A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) at C1D1.
* Signed and dated informed consent.
Exclusion Criteria:
* Known prior severe hypersensitivity to investigational products or any component in their formulations, including known severe hypersensitivity reactions to monocolonal antibodies.
* 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.
* Prior organ transplantation including allogenic stem cell 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.
* Known history of testing positive for human immunodeficiency virus (HIV or known acquired immunodeficiency syndrome (AIDS).
* Positive HBV surface antigen or HCV t…
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (DLT)
Timeframe: Cycle 1 of the treatment period (28 days)