18 and older, any sex, with Clear Cell Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) in Abemaciclib Arm (Arm 1)Primary· From the start of protocol treatment until disease progression or deaths. The total duration assessed was up to 3 months, as all patients either progressed, died, or withdrew from the study within that timeframe.
ORR is defined as percentage of patients with partial (PR) or complete response (CR) as best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by central review. Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.
Group
Value
95% CI
Abemaciclib-Arm 1
0
Progression-free Survival (PFS) in Abemaciclib Arm (Arm 1)Secondary· From trial treatment start to the earlier of progression or death due to any cause. The total duration assessed was up to 3 months, as all patients either progressed, died, or withdrew from the study within that timeframe.
PFS is measured from the start of treatment until documented progression by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) or death from any cause or censored at the last disease evaluation. PFS will be estimated using the method of Kaplan-Meier with 95% confidence intervals.
Imaging assessments will be performed every 8 weeks during the first six months of the study, then every 12 weeks thereafter.
Group
Value
95% CI
Abemaciclib-Arm 1
1.8
1.5 – 1.9
Overall Survival (OS) in Abemaciclib Arm (Arm 1)Secondary· From trial treatment start to death due to any cause or date last known alive, up to 23 months
OS is measured from the start of treatment until date of death from any cause or censored at the date of last follow-up. OS will be estimated using the method of Kaplan-Meier with 95% confidence intervals.
Group
Value
95% CI
Abemaciclib-Arm 1
9.1
2.1 – 15.3
Adverse events — posted to ClinicalTrials.gov
Time frame: For "Adverse event" reporting, the time frame was from start of protocol treatment until 90 days after treatment discontinuation, or until initiation of new cancer-directed treatment, or until death (whichever occurred first), up to 3.3 months. For "All-cause mortality" reporting, the time frame was from start of protocol treatment until deaths from any cause or until the date of last follow up for alive patients, up to 23 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This research study will assess whether abemaciclib alone or in combination with MK-6482 are safe and effective in slowing down the growth of clear cell renal cell carcinoma (ccRCC).
The names of the study drugs in this investigational combination are:
* Abemaciclib
* MK-6482
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer
· Phase 3
· not yet recruiting
NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco
· Phase 2
· not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi
· Phase 2
· not yet recruiting
NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis
· Phase 1, PHASE2
· recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer
· Phase 2
· enrolling by invitation
Other recruiting trials for Clear Cell Renal Cell Carcinoma
Currently open trials in the same condition.
NCT06863311 — Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear C
· Phase 2
· recruiting
NCT07227415 — Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Antica
· Phase 1, PHASE2
· recruiting
NCT07187778 — Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal
· Phase 2
· recruiting
NCT07389629 — Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
· Phase 2
· recruiting
NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres
· Phase 1
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 25 July 2025
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/NCT04627064.