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NCT06860386
A Phase II Study Assessing the Feasibility and Clinical Efficacy of Adaptive Immunotherapy Combination With VEGFR-TKI in Patients With Advanced Renal Cell Carcinoma
Phase 2 trial testing Pembrolizumab in Renal Cell Carcinoma in 75 participants. Suspended.
1 September 2026
Quick facts
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 25 February 2025 |
| Primary completion | 1 September 2026 |
| Estimated completion | 1 February 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
- Axitinib — full drug profile →
Conditions studied
- Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
- Clear Cell Renal Cell Carcinoma — all drugs for Clear Cell Renal Cell Carcinoma →
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Renal Cell Carcinoma or Clear Cell Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Recruitment Rate Feasibility
Time frame: Up to 36 Months
Measured as the percentage of eligible patients with a \>20% tumor response who consent to participate in the adaptive therapy. Successful enrollment if at least 70% of eligible patients agree to participate in the adaptive therapy -
Progression Free Survival (PFS)
Time frame: Up to 12 Months
Measured from the start of treatment until the point of disease progression or death from any cause.
Sponsor's own description
This is a Phase II Clinical Trial that will evaluate the use of adaptive dosing of pembro-axi in patients with Metastatic Clear Cell Renal Cell Carcinoma (mccRCC).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06860386
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Renal Cell Carcinoma
Currently open trials in the same condition.
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- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
Other H. Lee Moffitt Cancer Center and Research Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06860386 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06860386.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing