Study Stopped
Portfolio re-prioritization
A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer
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
1 other identifier
interventional
18
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2017
CompletedApril 30, 2018
April 1, 2018
1.5 years
August 28, 2015
April 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.
Safety follow-up is 70 days from last study drug dose.
Study Arms (1)
Varlilumab and Atezolizumab
EXPERIMENTALInterventions
Treatment cycles are 12 weeks each with varlilumab and atezolizumab administered every 3 weeks. During the treatment phase of the study, eligible patients will receive varlilumab for up to 3 cycles (with a 4th cycle possible following discussion with the Medical Monitor). There is no limit on the number of cycles of atezolizumab. Patients may be discontinued from receiving study treatment (atezolizumab or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable. Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg, or 3 mg/kg. The dose of atezolizumab is 1200 mg.
Eligibility Criteria
You may qualify if:
- 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.
- Documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
- Progressed or intolerant to at least 1 approved prior anticancer regimen.
- Measurable (target) disease.
- Life expectancy ≥ 12 weeks.
- 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.
- Must have available tumor tissue and consent to biopsy while on study.
- Patients with asymptomatic treated CNS metastasis may be enrolled after discussion with the Medical Monitor.
- ECOG of 0 or 1.
You may not qualify if:
- Prior therapy with varlilumab or with an anti-CD27 antibody.
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 therapy.
- Use of any experimental immunotherapy.
- Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.
- Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned state of study treatment.
- 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.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
- 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.
- Active, untreated CNS metastases.
- Active autoimmune disease or a documented history of autoimmune disease.
- Active diverticulitis.
- Significant cardiovascular disease including CHF, leptomeningeal disease, poorly controlled hypertension, or an MI within 6 months prior to dosing.
- Known alcohol or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celldex Therapeuticslead
- Genentech, Inc.collaborator
Study Sites (4)
University of California - San Francisco
San Francisco, California, 94550, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2015
First Posted
September 7, 2015
Study Start
October 1, 2015
Primary Completion
April 1, 2017
Study Completion
May 22, 2017
Last Updated
April 30, 2018
Record last verified: 2018-04