AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease

Who is this study for? Patients with Metastatic Prostate Cancer
What treatments are being studied? Atezolizumab+Cabozantinib S-malate
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male subject aged \>= 18 years

• Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology

• Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state

• Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and/or extraskeletal disease

• Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, darolutamide)

• Eastern Cooperative Oncology Group (ECOG) performance Status =\< 2

• Effective castration with serum testosterone levels =\< 0.5 ng/mL (=\<1.7 nmol/L)

• Tumor tissue available (archival or recent tumor biopsy). If no tumor tissue is available, patients can be enrolled after approval from Principal Investigator.

• Absolute neutrophil count (ANC) \>= 1500/mm\^3 without granulocyte colony-stimulating factor support

• White blood cell count \>= 2500/uL

• Lymphocyte count \>= 0.5 x 10\^9/L (500/uL)

• Platelet count \>= 100,000/mm\^3 without transfusion in the 2 weeks prior to cycle 1 day 1 (C1D1)

• Hemoglobin \>= 9 g/dL

• Serum albumin \>= 2.5 g/dl

• For patients not receiving therapeutic anticoagulation: prothrombin time (PT)/International normalized ratio (INR) or partial thromboplastin time (PTT) test \< 1.5 x institutional upper limit of normal (ULN). For patients receiving therapeutic anticoagulation: stable anticoagulant regimen as determined by Investigator

• Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN). For subjects with Gilbert's disease =\< 3 x institutional ULN

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 × institutional ULN

⁃ Subjects with liver metastases will be allowed to enroll with AST and ALT levels =\< 5 x institutional ULN

• Alkaline phosphatase (ALP) =\< 3 × institutional ULN. Patients with documented liver or bone metastases: ALP =\< 5 x institutional ULN

• Serum creatinine =\< 1.5 x institutional ULN or calculated creatinine clearance \>= 40 mL/min by Cockcroft-Gault formula

• Urine protein/creatinine ration (UPCR) =\< 1mg/mg (=\< 113.2 mg/mmol), or 24-hour (h) urine protein =\< 1 g

• Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment

• Male subjects must agree to use a condom during intercourse for the duration of study therapy

• Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator and/or stable on supportive therapy

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

• Capable of understanding and complying with the protocol requirements

Locations
United States
Utah
Huntsman Cancer Institute/University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Susan Sharry
susan.sharry@hci.utah.edu
801-585-3453
Time Frame
Start Date: 2022-03-11
Estimated Completion Date: 2027-01
Participants
Target number of participants: 33
Treatments
Experimental: Treatment (cabozantinib, atezolizumab)
Patients receive cabozantinib PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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