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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149159
Recruitment Status : Withdrawn (This study is withdrawn due to feasibility issues.)
First Posted : May 11, 2017
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Drug: Nivolumab Drug: Ipilimumab Radiation: Steriotactic radiation therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018


Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab + SRT Drug: Nivolumab
Nivolumab will be given every 21 days for the first 12 weeks at a dose of 3mg/kg. After 12 weeks, the dose will be 240mg and will be given every 14 days.
Other Name: opdivo

Drug: Ipilimumab
Ipilimumab will be given at a dose of 1mg/kg every 21 days for up to 12 weeks.

Radiation: Steriotactic radiation therapy
The dose of radiation will be 6 Gy daily x 5 days. Radiation will be given between the first and second doses of ipilimumab plus nivolumab.




Primary Outcome Measures :
  1. Number of patients with a partial or complete response [ Time Frame: 12 weeks ]
    The response rate of combined ipilimumab and nivolumab plus STR will be determined using irRECIST criteria.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years ]
    PFS will be determined from the onset of treatment to the time of documented disease progression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149159


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Bristol-Myers Squibb
Investigators
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Principal Investigator: Michael Lilly, MD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03149159    
Other Study ID Numbers: 102576
CA209-927 ( Other Grant/Funding Number: BMS )
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents