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Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

NCT04052204•Pfizer

View on ClinicalTrials.gov

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).

Detailed Description

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-tumor activity across combinations of therapy. Combination A will enroll participants with SCCHN. Combination B and C will enroll participants with mCRPC

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (5)

University of Rochester Medical Center

Rochester, New York, United States

GZA Ziekenhuizen campus Sint-Augustinus

Wilrijk, Antwerpen, Belgium

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Hospital Quirón Barceloma

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Key Dates

Start Date

December 30, 2019

Primary Completion Date

September 29, 2020

Completion Date

September 29, 2020

Last Updated

October 14, 2021

Enrollment

ACTUAL participants

Conditions

Squamous Cell Carcinoma of the Head and Neck (SCCHN)Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

avelumab

DRUG

Bempegaldesleukin

DRUG

talazoparib

DRUG

enzalutamide

DRUG

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

COMPLETED

EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)

NCT04516161

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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