Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 2 Pilot Study of the Efficacy and Safety of Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134182
• Other study ID #: KCRB16102019
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Kidney Cancer Research Bureau
• Contact: Ilya Tsimafeyeu, MD
• Phone: +79265646581
• Email: kidneycancer[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this Phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-PD-1 antibody, and ipilimumab, an anti-CTLA-4 antibody, in T1aN0M0 clear-cell RCC patients ineligible for surgical treatment.

Description:

Surgery remains the standard curative-intent therapy for localized renal cell carcinoma (RCC). Thus, systemic therapy for RCC should still be considered only in patients who have contraindications to surgery.

Results of Phase 3 CheckMate 214 study showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic RCC patients with a complete response rate of 11% (Motzer et al. Lancet Oncology 2019). Median time to objective response was 2.8 months. Among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan, whereas most converted from the partial response at a median of 6.9 months or from the stable disease at a median of 11.3 months.

We hypothesize that this combination could completely eliminate primary tumors in patients with small primary (less than 4 cm) ineligible for surgical treatment. There are no studies evaluating checkpoint inhibitors in this setting in RCC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cytologically proven clear-cell RCC

2. CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)

3. Inability to perform surgery for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason

4. No contradictions to nivolumab and ipilimumab

5. Age 18 or older

6. Written informed consent

Exclusion Criteria:

1. prior treatment for RCC

2. pregnant or nursing

3. history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., New York Heart Association class III or IV)

4. evidence of metastatic disease

5. local and/or systemic infections requiring antibiotics within 28 days prior to study entry

6. other malignancy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Nivolumab
3 mg/kg intravenously every 2 weeks during 16 weeks
• Ipilimumab
1 mg/kg intravenously every 3 weeks for four doses

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Russian Cancer Research Center	Moscow
Russian Federation	Russian Scientific Center of Roentgenoradiology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	percentage of patients with localized RCC who have no tumor in kidney	16 weeks
Secondary	Objective response rate	percentage of patients with localized RCC who have no tumor in kidney or tumor shrinkage more than 30%	16 weeks
Secondary	3-year disease-free survival rate	percentage of patients who are disease free at 3 years after treatment start	3 years
Secondary	5-year survival rate	percentage of patients who are alive at 5 years after treatment start	5 years
Secondary	Rate of adverse events	percentage of patients who have adverse events	16 weeks