Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
NCT04052204
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors | ||||||
Official Title ICMJE | 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 | ||||||
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-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 | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: Combination A: 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 Combination B: Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will enroll participants with DDR defect positive mCRPC. Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 3 | ||||||
Original Estimated Enrollment ICMJE | 120 | ||||||
Actual Study Completion Date ICMJE | September 29, 2020 | ||||||
Actual Primary Completion Date | September 29, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Poland, Spain, United States | ||||||
Removed Location Countries | Canada, Italy | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04052204 | ||||||
Other Study ID Numbers ICMJE | B9991040 2019-001358-24 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |