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A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Status
Active
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05805501
Protocol IDs
BO43936 (primary)
NCI-2023-03569
Study Sponsor
Hoffmann-La Roche

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT)
and axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma
(ccRCC).

Eligibility

  1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  2. International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6)
  3. Measurable disease with at least one measurable lesion
  4. Histologically confirmed ccRCC with or without sarcomatoid features
  5. Negative for HIV, hepatitis B, or hepatitis C virus (HCV)

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.