Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
NCT ID: NCT04052204
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2019-12-30
2020-09-29
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
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
TREATMENT
NONE
Study Groups
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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
avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Bempegaldesleukin
Investigational CD122-biased cytokine agonist
Combination B
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.
avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Bempegaldesleukin
Investigational CD122-biased cytokine agonist
talazoparib
poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor
Combination C
Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC
avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Bempegaldesleukin
Investigational CD122-biased cytokine agonist
enzalutamide
androgen receptor inhibitor
Interventions
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avelumab
Investigational fully human anti-PD-L1 monoclonal antibody
Bempegaldesleukin
Investigational CD122-biased cytokine agonist
talazoparib
poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor
enzalutamide
androgen receptor inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Nektar Therapeutics
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-001358-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B9991040
Identifier Type: -
Identifier Source: org_study_id