Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial

NCT05168618 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: HCI143814NCI-2021-13110P30CA042014
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  Measured per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with a 95% confidence interval.

  At 24 weeks

Secondary Outcomes (5)

• Prostate-specific antigen (PSA) progression-free survival (PFS)

  From treatment initiation until documented clinical or radiographic progression or death from any cause, assessed up to 3 years

• PSA levels

  Baseline up to 30 days after completion of study treatment

• Progression-free survival (PFS)

  From the start date of treatment and the date of first recurrence or death from any cause, assessed up to 3 years after the initiation of therapy

• Overall survival

  From trial initiation and death of any cause, assessed up to 5 years

• Incidence of adverse events (AEs)

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (cabozantinib, atezolizumab)

EXPERIMENTAL

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.

Biological: Atezolizumab; Drug: Cabozantinib S-malate

Interventions

Atezolizumab BIOLOGICAL

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq

Treatment (cabozantinib, atezolizumab)

Cabozantinib S-malate DRUG

Given PO

Also known as: BMS-907351, Cabometyx, Cometriq, XL-184, XL184

Treatment (cabozantinib, atezolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)
• Prior treatment with cabozantinib, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies
• Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
• Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
• Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment
• Receiving other investigational agents
• Patients with measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria
• History of Leptomeningeal disease
• Uncontrolled tumor-related pain
• Note: Patients requiring pain medication must be on a stable regimen at study entry
• Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation
• Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment
• Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
• Major surgery (e.g., laparoscopic nephrectomy, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment or anticipation of need for a major surgical procedure during the study. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
• Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \> 90%), such as locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

atezolizumab; cabozantinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Umang Swami

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Sharry

CONTACT

801-585-3453; susan.sharry@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: March 11, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)