Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Pembrolizumab for Clear Cell Renal Cell Carcinoma

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Official registry: https://clinicaltrials.gov/study/NCT06661720 · Alliance for Clinical Trials in Oncology · enrollment listed as 1,040

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pembrolizumab, Tivozanib, or Biospecimen Collection. The registry lists allocation as randomized. This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC).

They plan to enroll about 1,040 people at 429 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE

Interventions: Pembrolizumab, Tivozanib, Biospecimen Collection, MRI, Computed Tomography, Biopsy, Questionnaire Administration

Primary outcome (registry wording): Disease-free survival (DFS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
  • Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
  • Intermediate-high risk RCC:
  • pT2 grade 4 or sarcomatoid features, N0M0
  • pT3 any grade N0, M0
  • pT4, any grade, N0, M0
  • pT, any stage., any grade, N+, M0

Public study contact (from the registry)

Aishwarya Vijendran

773-702-9171

guprotocols@alliancenctn.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

429 listed

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FAQ about this NCT record

Is NCT06661720 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06661720?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06661720?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary