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Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent Renal Cell Carcinoma (RCC)

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ClinicalTrials.gov Identifier: NCT02962804
Recruitment Status : Withdrawn (Due to competing trials. Stopped before IRB approval.)
First Posted : November 11, 2016
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
There are two primary aims in the study: 1) to determine the tolerability and feasibility of combination hypofractionated radiation therapy and PD-1 inhibition with nivolumab, and 2) to determine the ability of hypofractionated radiation therapy to enhance response rate from PD-1 inhibition versus PD-1 inhibition alone by comparing the observed response rate under the combination therapy with a previously reported response rate under inhibition alone.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Nivolumab Radiation: Radiation Phase 2

Detailed Description:
Patients with metastatic or recurrent renal cell cancer who have progressed on standard Tyrosine Kinase Inhibitor (TKI) therapy and who have metastatic or primary tumors suitable for palliative radiation will be eligible for this study. Treatment will consist of nivolumab plus hypofractionated radiation therapy. The primary endpoint will be objective response rate, which will be compared against the historical control of 25% using nivolumab alone as established in the CHECKMATE 025 clinical trial. Patients will continue on nivolumab until disease progression or withdrawal of consent. Follow-up will continue for 2 years.

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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: Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent RCC
Actual Primary Completion Date : February 2, 2017

Arm Intervention/treatment
Experimental: Nivolumab plus radiation
Nivolumab plus radiation
Drug: Nivolumab
240 mg per IV infusion over 60 minutes every 14 days (+/- 2 days) until disease progression or participant withdrawal from study
Other Name: OPDIVO

Radiation: Radiation
Radiation to at least 1 site (up to 3) of primary or metastasis, 5 fractions - delivered over 2 weeks, starting 1-3 days post-nivolumab administration. Recommended dose range is 6 Gy-12 Gy per fraction.

Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Every 3 months up to 2 years or progression ]
    Objective response rate (ORR) defined as the sum of partial response (PR) and complete response (CR). Timeframe will be best response from registration to end of treatment.

Secondary Outcome Measures :
  1. ORR at irradiated sites [ Time Frame: Every 3 months up to 2 years or progression ]
  2. ORR at un-irradiated sites [ Time Frame: Every 3 months up to 2 years or progression ]
  3. Progression free survival (PFS) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Histologically confirmed history of renal cell carcinoma (all variants are acceptable)
  2. Progression or recurrence after at least one prior tyrosine kinase inhibitor therapy including, but not limited to: sunitinib, pazopanib, axitinib.
  3. At least 1 site (primary or metastasis) amenable to hypofractionated radiation therapy and appropriate for radiation therapy as part of standard of care per medical, urologic or radiation oncologist discretion. NOTE: CT / MRI imaging to have been completed no more than 30 days before enrollment on study.

    Potential indications for radiation therapy include (but are not limited to):

    • Painful bone or soft tissue metastasis
    • Symptoms from mass effect caused by tumor
    • Prevention of impending symptoms from tumor
    • Hemoptysis due to tumor
    • Limited oligometastasis
    • Isolated region of progression
  4. Patients with prior IL-2 treatment are eligible
  5. At least 14 days since any prior therapy
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
  7. Adequate organ and marrow function as defined below:

    • leukocytes ≥ 2,000/mcL
    • absolute neutrophil count ≥ 1,000/mcL
    • platelets ≥ 100,000/mcL
    • total bilirubin within normal institutional limits
    • AST(SGOT) ≤ 2.5 X institutional upper limit of normal
    • ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
  8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception. Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.

Exclusion Criteria:

  1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. Men who are trying to father a child.
  3. Presence of a condition or abnormality that in the opinion of the study-delegated investigator would compromise the safety of the patient or the quality of the data.
  4. Requirement for high dose steroids: dexamethasone > 2 mg per day or equivalent

    • NOTE: Per OPDIVO (Nivolumab) package insert, no formal pharmacokinetic drug-drug interaction studies have been conducted with OPDIVO (Nivolumab) - therefore, no other concomitant medications will exclude potential participants.
  5. Life expectancy < 6 months.
  6. Other active malignancy (patients with no evidence of disease (NED) or are in remission are eligible).
  7. Patient has untreated brain metastases. Patients are eligible after documented stable or improved brain metastases at least 1 month after treatment of brain metastases.
  8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to PD-1 Inhibitors used in study.
  9. 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.
  10. Patients with active, known or suspected autoimmune disease (not including type 1 diabetes mellitus, hypothyroidism, skin disorders not requiring systemic treatment or conditions not expected to recur).
  11. Patients with interstitial lung disease
  12. Patients receiving concurrent other cancer-directed therapy including, but not limited to, Tyrosine Kinase Inhibitor (TKI), Mammalian Target Of Rapamycin (mTOR) inhibition and/or chemotherapy.

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): NCT02962804

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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
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Principal Investigator: Xinglei Shen, MD University of Kansas Medical Center
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02962804    
Other Study ID Numbers: IIT2016XSGURadPlusPD1RenalCC
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Keywords provided by University of Kansas Medical Center:
renal cell
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action