Status:
TERMINATED
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Lead Sponsor:
Pfizer
Collaborating Sponsors:
EMD Serono
Nektar Therapeutics
Conditions:
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-21...
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 activit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04052204
Start Date
December 30 2019
End Date
September 29 2020
Last Update
October 14 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
2
GZA Ziekenhuizen campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium, 2610
3
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland, 02-781
4
Hospital Quirón Barceloma
Barcelona, Spain, 08023