Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumours

Official Title

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 Tumours


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).

Trial Description

Primary Outcome:

  • Dose Limiting Toxicity (DLT)
  • Combination A: Confirmed objective response (OR)
  • Combination B: Confirmed soft tissue OR
  • Combination C: Confirmed prostate specific antigen (PSA) response
Secondary Outcome:
  • Time to tumour response
  • Duration of tumour response
  • Progression Free Survival (PFS)
  • Overall survival (OS)
  • Time to prostate-specific antigen (PSA) progression for mCRPC patients
  • Time to prostate-specific antigen (PSA) response for mCRPC patients
  • Duration of prostate-specific antigen (PSA) repsonse for mCRPC patients
  • Circulating tumour cells (CTC) count and CTC0 for Combination C only patients
  • Biomarker PD-L1
  • Maximum serum concentration (Cmax) for avelumab
  • Trough serum concentration (Ctrough) of avelumab
  • Trough and maximum plasma concentration of bempegaldesleukin (NKTR-214)
  • Trough plasma concentration for talazoparib
  • Trough plasma concentration Ctrough for enzalutamide and N-desmethyl-enzalutamide
  • Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb) against avelumab
  • Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb) against bempegaldesleukin (NKTR-214) and IL-2
Phase 1b/ Phase 2 Design Phase 1b will be the sequential dose-finding study. Once the Phase 1b component is completed, Phase 2 will be initiated to further evaluate the safety and anti-tumour activity across combinations of therapy. Combination A will enroll participants with SCCHN. Combination B and C will enroll participants with mCRPC

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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