Clinical trial · Interventional
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| avelumab | Drug | Avelumab | ALIAS |
| Bempegaldesleukin | Drug | — | UNRESOLVED |
| enzalutamide | Drug | Enzalutamide | ALIAS |
| talazoparib | Drug | Talazoparib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Combination A
- description
- Avelumab + Bempegaldesleukin (NKTR-214) for treatment of locally recurrent (not amendable for treatment with curative intent) or metastatic squamous cell carcinoma of the head and neck
- interventionNames
- Drug: avelumab
- Drug: Bempegaldesleukin
- type
- EXPERIMENTAL
- label
- Combination B
- description
- Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will focus on enrolling participants with DDR defect positive mCRPC.
- interventionNames
- Drug: avelumab
- Drug: Bempegaldesleukin
- Drug: talazoparib
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 test indicating acute or chronic infection.. * Active infection requiring systemic therapy * Clinically significant (i.e., active) cardiovascular disease including the following: documented left ventricular ejection fraction (LVEF) \<50% by ECHO/MUGA; cerebral vascular accident/stroke or transient ischemic attack; myocardial infarction; unstable angina; congestive heart failure or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring medication. * Diagnosis of any other malignancy within 2 years prior to C1D1, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix and for Combination A only, low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration) or adequately treated prostate cancer. * Current use of immunosuppressive medication at the time of study enrollment. * Major surgery within 4 weeks prior to study enrollment. * Conditions that may impair intake or absorption such as inability to swallow capsules or tablets; known malabsorption syndrome; or baseline diarrhea ≤ Grade 1. * Participation in other studies involving investigational drug(s) within 2 weeks prior to C1D1.
References
Publications (0)
Data not yet available