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

NCT04134182 | Unknown Phase 2

• 1 other identifier: KCRB16102019
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  percentage of patients with localized RCC who have no tumor in kidney

  16 weeks

Secondary Outcomes (4)

• Objective response rate

  16 weeks

• 3-year disease-free survival rate

  3 years

• 5-year survival rate

  5 years

• Rate of adverse events

  16 weeks

Study Arms (1)

Nivolumab + Ipilimumab

EXPERIMENTAL

Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

3 mg/kg intravenously every 2 weeks during 16 weeks

Also known as: Opdivo

Nivolumab + Ipilimumab

Ipilimumab DRUG

1 mg/kg intravenously every 3 weeks for four doses

Also known as: Yervoy

Nivolumab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologically proven clear-cell RCC
• CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)
• 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
• No contradictions to nivolumab and ipilimumab
• Age 18 or older
• Written informed consent

You may not qualify if:

• prior treatment for RCC
• pregnant or nursing
• 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)
• evidence of metastatic disease
• local and/or systemic infections requiring antibiotics within 28 days prior to study entry
• other malignancy

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (2)

N.N. Blokhin Russian Cancer Research Center

Moscow, Russia

RECRUITING

Russian Scientific Center of Roentgenoradiology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ilya Tsimafeyeu, MD

  Kidney Cancer Research Bureau

  STUDY DIRECTOR

Central Study Contacts

Ilya Tsimafeyeu, MD

CONTACT

+79265646581; kidneycancer@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: October 16, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)