Atezolizumab + Cabozantinib in Patients w/ Metastatic, Refractory Pancreatic Cancer

NCT04820179 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2108097176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is one of the leading causes of cancer deaths in the United States with limited treatment options, especially for those patients with metastatic disease. Combination treatment with cabozantinib and atezolizumab, has demonstrated safety for the treatment of other cancers and has shown promise in preclinical studies utilizing patient derived pancreas organoids. In this study, patients with refractory, metastatic pancreatic cancer will receive combination cabozantinib + atezolizumab and the efficacy of this treatment will be assessed through overall response rate (ORR), disease control rate (DCR), median overall survival (mOS), and median progression free survival (mPFS). Safety and tolerability of combination cabozantinib plus atezolizumab in metastatic pancreatic cancer patients will also be assessed and immune profiling pre- and post-treatment will be explored.

Conditions

Metastatic Pancreatic Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate or Stable Disease

  To evaluate the efficacy of cabozantinib plus atezolizumab in patients with refractory metastatic pancreatic cancer through overall response rate (ORR) changes or stable disease (SD) after 9 weeks of treatment.

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

Secondary Outcomes (4)

• Adverse Event

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

• Toxicities

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

• Disease Control Rate

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

• Survival

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

Other Outcomes (3)

• T2 Signal

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months)

• Immune System Effects

  Baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression (assessed up to 100 months)

• Tumor Response

  Participants will be evaluated for response every 3 cycles (each cycle is 21 days) thereafter until disease progression or death from any cause, whichever occurs first (an average of 6 months).

Study Arms (1)

Cabozantinib 40mg + Atezolizumab 1200mg

EXPERIMENTAL

Cabozantinib 40 mg, tablets, oral administration, once daily, continuously. Atezolizumab 1200 mg, administered intravenously, on Day 1 of every 21 day cycle.

Drug: Cabozantinib + Atezolizumab

Interventions

Cabozantinib + Atezolizumab DRUG

All the subjects will be treated with the combination of cabozantinib and atezolizumab until disease progression, unacceptable toxicity or patient consent withdrawal (whichever occurs first).

Cabozantinib 40mg + Atezolizumab 1200mg

Eligibility Criteria

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

You may qualify if:

• Stage IV pancreatic adenocarcinoma, confirmed by histology or cytology. (Note: the primary pancreatic adenosarcoma must be confirmed by histology or cytology. The stage IV metastatic disease does not necessarily need to be confirmed by histology or cytology).
• Clinical and/or radiographic progression on and/or intolerance to and/or ineligibility for treatment with at least one of the following: a fluoropyrimidine or gemcitabine based chemotherapy treatment regimens
• Radiographically measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Images (MRI or CT Scan) must be completed within 28 days prior to treatment start.
• Age ≥ 18 years

You may not qualify if:

• Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
• Absolute neutrophil count (ANC) ≥ 1500/µL without granulocyte colony-stimulating factor support.
• White blood cell count ≥ 2500/µL
• Platelets ≥ 100,000/µL without transfusion.
• Hemoglobin ≥ 9 g/dL (≥ 90 g/L).
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions:
• Patients with documented liver metastases: AST and ALT ≤ 5 x ULN Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
• Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
• Serum albumin ≥ 2.8 g/dl
• (PT)/INR or partial thromboplastin time (PTT) test \< 1.3 x the laboratory ULN
• Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation:
• Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72) Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85
• Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g
• For patients receiving therapeutic anticoagulation, they must have a stable anticoagulant regimen.
• No clinically significant hypertension as per treating physician or if hypertension, adequate control with anti-hypertensives

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

cabozantinib; atezolizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Rachna Shroff, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

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: March 22, 2021
• First Posted: March 29, 2021
• Study Start: October 12, 2021
• Primary Completion: February 20, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)