A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer



Status:Terminated
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Renal Impairment / Chronic Kidney Disease, Urology, Bladder Cancer
Therapuetic Areas:Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/2/2018
Start Date:October 2015
End Date:May 22, 2017

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A Phase l/ll, Open Label, Dose-escalation Study of Varlilumab (CDX-1127) in Combination With Atezolizumab (MPDL3280A, Anti-PD-L1) in Patients With Advanced Cancer

This is a study to determine the clinical benefit (how well the drug works), safety and
tolerability of combining varlilumab and atezolizumab. Phase l of the study will enroll
patients with a number of tumor types; Phase ll will enroll only patients with renal cell
carcinoma (RCC).*

*Note: This Study was terminated prior to initiation of Phase II

Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on
certain immune cells and may act to promote anti-tumor effects.

Atezolizumab is an engineered anti-PD-L1 antibody.

This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody
varlilumab in combination with atezolizumab.

Eligible patients that enroll in the dose escalation portion of the study will be assigned to
one of three dose levels of varlilumab in combination with 1200 mg of atezolizumab. The first
phase of the study will enroll up to 18 patients and test the safety profile of the
combination of varlilumab and atezolizumab in patients with various tumor types and determine
which dose of varlilumab will be studied in Phase ll* of the study which will enroll only
patients with RCC.

*Note: This Study was terminated prior to initiation of Phase II.

All patients enrolled in the study will be closely monitored to determine if there is a
response to the treatment as well as for any side effects that may occur.

Inclusion Criteria:

1. Unresectable stage lll or IV, histologically confirmed diagnosis of one of the
following solid tumors:

- Phase l: Melanoma, RCC, triple negative breast cancer, bladder cancer, head and
neck cancer or non-small cell lung cancer.

2. Documented progressive disease based on radiographic, clinical or pathologic
assessment during or subsequent to last therapy.

3. Progressed or intolerant to at least 1 approved prior anticancer regimen.

4. Measurable (target) disease.

5. Life expectancy ≥ 12 weeks.

6. If of childbearing potential (male or female), agrees to practice an effective form of
contraception during study treatment and for at least 90 days following last treatment
dose.

7. Must have available tumor tissue and consent to biopsy while on study.

8. Patients with asymptomatic treated CNS metastasis may be enrolled after discussion
with the Medical Monitor.

9. ECOG of 0 or 1.

Exclusion Criteria:

1. Prior therapy with varlilumab or with an anti-CD27 antibody.

2. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.

3. Use of any experimental immunotherapy.

4. Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory
therapy within 3 months prior to start of study treatment.

5. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to
the planned state of study treatment.

6. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or
radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of
study treatment.

7. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within
2 weeks prior to first dose of study treatment.

8. Other prior malignancy, except for adequately treated basal or squamous cell skin
cancer or in situ cancers; or any other cancer from which the patient has been
disease-free for at least 3 years.

9. Active, untreated CNS metastases.

10. Active autoimmune disease or a documented history of autoimmune disease.

11. Active diverticulitis.

12. Significant cardiovascular disease including CHF, leptomeningeal disease, poorly
controlled hypertension, or an MI within 6 months prior to dosing.

13. Known alcohol or drug abuse.
We found this trial at
4
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David McDermott, MD
Phone: 617-632-7034
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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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Daniel George, MD
Phone: 919-681-1030
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Martin Voss, MD
Phone: 646-422-4631
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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San Francisco, California 94143
Principal Investigator: Lawrence Fong, MD
Phone: 415-514-6248
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San Francisco, CA
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