Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and NSCLC



Status:Recruiting
Conditions:Lung Cancer, Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/20/2018
Start Date:August 2016
End Date:June 2019
Contact:Clinical Trials Administrator
Email:clinicaltrials@calithera.com

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A Phase 1/2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Glutaminase Inhibitor CB-839 in Combination With Nivolumab in Patients With Advanced/Metastatic Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in
patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in
patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

During Phase 1, patients will be enrolled into escalating dose cohorts to determine the
recommended phase 2 dose (RP2D).

In Phase 2, patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung
cancer will be enrolled into separate cohorts.

All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.

Addition eligibility criteria based on tumor type apply

Inclusion Criteria:

- Ability to provide written informed consent in accordance with federal, local, and
institutional guidelines

- Histological or cytological diagnosis of metastatic cancer or locally advanced cancer
that is not amenable to local therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Life Expectancy of at least 3 months

- Adequate hepatic, renal, cardiac, and hematologic function

- Measurable disease by RECISTv1.1 criteria

- Resolution of treatment-related toxicities except alopecia

Exclusion Criteria:

- Unable to receive oral medications

- Unable to receive oral or IV hydration

- Intolerance to prior anti-PD-1/PD-L1 therapy

- Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)

- Any other current or previous malignancy within 3 years except protocol allowed
malignancies

- Chemotherapy, Tyrosine Kinase Inhibitor therapy, radiation therapy or hormonal therapy
within 2 weeks

- Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note:
Some cohort exceptions allow anti-PD-1 therapy)

- Active known or suspected exclusionary autoimmune disease

- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks

- History of known risks factors for bowel perforation

- Symptomatic ascites or pleural effusion

- Major surgery within 28 days before Cycle 1 Day 1

- Active infection requiring parenteral antibiotics, antivirals, or antifungals within 2
weeks prior to first dose of study drug

- Patients who have HIV, Hepatitis B or C

- Conditions that could interfere with treatment or protocol-related procedures

- Active and/or untreated CNS disease or non-stable brain metastases
We found this trial at
17
sites
Aurora, Colorado 80045
Principal Investigator: Elaine Lam, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David McDermott, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Richard Lee, MD
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Boston, MA
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
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Athens, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Geoffrey Shapiro, MD
Phone: 855-320-2090
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Afshin Dowlati, MD
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Cleveland, OH
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4100 John R Street
Detroit, Michigan 48201
Principal Investigator: Ulka Vaishampayan, MD
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Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Funda Meric-Bernstam, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Kimryn Rathmell, MD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Martin Voss, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Elaine Shum, MD
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Gary Schwartz, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Palo Alto, California 94304
Principal Investigator: Alice Fan, MD
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Palo Alto, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Naomi Haas, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Scottsdale, Arizona 85251
Principal Investigator: Michael Gordon, MD
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Scottsdale, AZ
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Seattle, Washington 98109
Principal Investigator: Scott Tykodi, MD, PhD
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Seattle, WA
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Tacoma, Washington 98405
Principal Investigator: Jorge Chaves, MD
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Tacoma, WA
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