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

Titre officiel

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

Sommaire:

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).

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov