Clinical trial NCT03149159: Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab
Official title: An Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic ccRCC.
* Age 18 years and older
* ECOG 0-1
* Progressive disease after treatment with single-agent nivolumab
* Life expectancy at least 3 months
* Presence of measurable disease per RECIST 1.1 criteria
* Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment
* Adequate organ system function
* WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Exclusion Criteria:

* Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol).
* Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs.

Note: Subjects are permitted to enroll if they have 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

* Presence of a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration.

Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

* Unstable angina or uncontrolled congestive heart failure
* Uncontrolled hypercalcemia
* Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Presence of other malignant diseases, except non-melanoma skin care
* History of allergy to study drug components.
* History of severe hypersensitivity reaction to any monoclonal antibody.
* Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration.
* Women must not be pregnant or breastfeeding. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration.
* Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated

Primary outcomes:
measure: Number of patients with a partial or complete response
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Lilly, MD
role: PRINCIPAL_INVESTIGATOR
References: