Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent Renal Cell Carcinoma (RCC)
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent RCC
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.
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.
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.
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.
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.
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