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Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors

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Pfizer

Status and phase

Terminated
Phase 2
Phase 1

Conditions

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

Treatments

Drug: talazoparib
Drug: avelumab
Drug: enzalutamide
Drug: Bempegaldesleukin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04052204
B9991040
2019-001358-24 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

3 participants in 3 patient groups

Combination A
Experimental group
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
Treatment:
Drug: Bempegaldesleukin
Drug: avelumab
Combination B
Experimental group
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.
Treatment:
Drug: Bempegaldesleukin
Drug: avelumab
Drug: talazoparib
Combination C
Experimental group
Description:
Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC
Treatment:
Drug: enzalutamide
Drug: Bempegaldesleukin
Drug: avelumab

Trial documents
2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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