- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03126461
SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
August 19, 2020 updated by: University of Texas Southwestern Medical Center
Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center - Dallas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic diagnosis of metastatic melanoma.
- Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab, nivolumab or other CTLA-4, PD-1 or PD-L1 inhibitors.
- Patients must have measurable disease in at least 2 non-radiated sites as defined by RECIST v1.1. All sites must be evaluated within 4 weeks prior to registration.
- Age ≥ 18 years.
- Eligible for SABR to 1-5 sites of disease (Refer to 3.2.10)
- Performance status ECOG 0-2.
Adequate organ and marrow function as defined below:
- leukocytes ≥ 1,000/mcL
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 75,000/mcl
total bilirubin < 2.5X institutional upper limit of normal or
- 3 in subjects with Gilbert's Syndrome
- AST(SGOT)/ALT(SPGT) ≤ 4 X institutional upper limit of normal
- creatinine < 4X institutional upper limit of normal
- hemoglobin >7g/dL
- Ability to understand and the willingness to sign a written informed consent.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:
- No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >4weeks prior to registration.
- No infection with HIV and no known history of hepatitis B or hepatitis C virus indicating acute or chronic infection or active TB.
- Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated (Surgery or radiation) and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or localized adenocarcinoma of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing.
- Patients are excluded if they have a history of prior treatment with ipilimumab, CTLA-4 inhibitor or agonist, nivolumab, PD-1 or PD-L1 inhibitor.
- Subjects who have had major surgery within 2 weeks prior to first dose of drug
- Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
- Uncontrolled adrenal insufficiency or active chronic liver disease
- Any history of CNS metastases that is not adequately treated (surgery or radiation ) >14 days prior to registration.
- Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
- Subjects with life expectancy < 6 months
- Subjects receiving any other investigational or standard antineoplastic agents.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SAbR plus ipilimumab plus nivolumab
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
|
For patients treated on the "GRID A" regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions).
For patients treated on the "GRID B" regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose.
Other Names:
ipilimumab 3mg/kg IV q3wk x 4
Other Names:
nivolumab 1 mg/kg IV q3wk x 4
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of tumor size from baseline to follow up
Time Frame: at 12, 24, 36 weeks
|
treatment response rate-RR based on RECISTv1.1
|
at 12, 24, 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease control rate
Time Frame: at 12, 24, 36 weeks
|
disease control rate defined as response plus stable disease based on RECISTv1.1
|
at 12, 24, 36 weeks
|
Number of treatment-related adverse events
Time Frame: 2 years
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
2 years
|
programmed death ligand-1 (PD-L1) expression
Time Frame: baseline, cycle 1 Day 1, and week 15
|
compare tumor PD-L1 expression at 3 time points
|
baseline, cycle 1 Day 1, and week 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kevin Albuquerque, MD, University of Texas Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
March 23, 2017
First Submitted That Met QC Criteria
April 21, 2017
First Posted (ACTUAL)
April 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 19, 2020
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Ipilimumab
Other Study ID Numbers
- STU 082016-058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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