Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Liver Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 5, 2017
End Date:December 2020
Contact:Exelixis Clinical Trials
Email:druginfo@exelixis.com
Phone:1-888-EXELIXIS (888-393-5494)

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A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary
efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in
subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including
bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant
prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer
(TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric
cancer and gastroesophageal junction cancer (GC/GEJC), colorectal cancer (CRC), head and neck
(H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in
the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination
with standard dosing regimen of atezolizumab will be established; in the Expansion Stage,
tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy
of the combination treatment in these tumor indications. Two exploratory single-agent
cabozantinib (SAC) cohorts will also be enrolled with UC or NSCLC subjects.

- Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or
recommended Expansion Stage dose of cabozantinib when taken in combination with a
standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks).

- Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR]
per RECIST 1.1) and safety of the recommended combination dose of cabozantinib with
atezolizumab in eighteen tumor-specific cohorts including subjects with advanced UC,
RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC, CRC, H&N, and DTC.

- Exploratory SAC Cohorts: Descriptive efficacy, safety, PK, and biomarker analyses of
single-agent cabozantinib in UC and NSCLC subjects

Inclusion Criteria:

1. Cytologically or histologically and radiologically confirmed solid tumor that is
inoperable, locally advanced, metastatic, or recurrent:

- Dose-Escalation Stage:

- Subjects with UC (including renal pelvis, ureter, bladder, urethra) after
prior platinum-based therapy, or

- Subjects with RCC (clear cell, non-clear cell histology) with or without
prior systemic anticancer therapy

- Expansion Stage:

- Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC,
TNBC, OC, EC, HCC, GC/GEJC, CRC, H&N cancer, and DTC as outlined above)

2. Measurable disease per RECIST 1.1 as determined by the investigator.

3. Tumor tissue material available (archival or recent tumor biopsy)

4. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior
treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive
therapy.

5. Age eighteen years or older on the day of consent.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

7. Adequate organ and marrow function.

8. Sexually active fertile subjects and their partners must agree to use medically
accepted methods of contraception.

9. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

1. Prior treatment with cabozantinib or immune checkpoint inhibitors including
anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts
5, 7,19 and 20. Other restrictions regarding prior therapy may apply.

2. Known brain metastases or cranial epidural disease unless adequately treated and
stable for at least 4 weeks before first dose of study treatment.

3. Concomitant anticoagulation with oral anticoagulants.

4. Subject is receiving systemic steroid therapy or any other form of immunosuppressive
therapy within 2 weeks prior to first dose of study treatment.

5. Administration of a live, attenuated vaccine within 30 days before first dose of study
treatment.

6. The subject has uncontrolled, significant intercurrent or recent illness, including,
but not limited to, an active or history of autoimmune disease or immune deficiency;
idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection
requiring systemic treatment, infection with human immunodeficiency virus (HIV),
AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for
tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).

7. Pregnant or lactating females.

8. Previously identified allergy or hypersensitivity to components of the study treatment
formulations.

9. Diagnosis of another malignancy within 2 years before first dose of study treatment.
We found this trial at
27
sites
201 Presidents Cir
Salt Lake City, Utah 84112
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Salt Lake City, UT
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Blacksburg, Virginia 24060
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Blacksburg, VA
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Boston, Massachusetts 02215
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Boston, MA
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Bronx, New York 10461
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Bronx, NY
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Camden, New Jersey 08103
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Camden, NJ
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Charlottesville, Virginia 22908
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Charlottesville, VA
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Dallas, Texas 75246
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Dallas, TX
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Denver, Colorado 80218
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Denver, CO
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Detroit, Michigan 48201
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Detroit, MI
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Duarte, California 91010
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Duarte, CA
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East Brunswick, New Jersey 08816
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East Brunswick, NJ
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Fairway, Kansas 66205
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Fairway, KS
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Harvey, Illinois 60426
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Harvey, IL
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Houston, Texas 77030
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Houston, TX
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Jacksonville, Florida 32224
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Jacksonville, FL
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La Jolla, California 92090
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La Jolla, CA
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Lubbock, Texas 79410
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Lubbock, TX
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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New Orleans, Louisiana 70112
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New Orleans, LA
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New York, New York 10029
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New York, NY
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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Omaha, Nebraska 68130
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Omaha, NE
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Phoenix, Arizona 85054
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Rochester, Minnesota 55905
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Rochester, MN
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Stanford, California 94305
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Stanford, CA
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Villejuif, Cedex 94805
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Villejuif,
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