Trial reportTumori2023
A multicenter phase 2 single arm study of cabozantinib in patients with advanced or unresectable renal cell carcinoma pre-treated with one immune-checkpoint inhibitor: The BREAKPOINT trial (Meet-Uro trial 03).
Trial report in Tumori, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03463681 (A Phase 2 Open Label Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma Pretreated With One immunochecKPOint INhibiTor), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2 Open Label Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma Pretreated With One immunochecKPOint INhibiTor (Anti PD1/PDL1): the BREAKPOINT Trial
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- The efficacy and safety of belzutifan inhibitor in patients with advanced or metastatic clear cell renal cell carcinoma: a meta-analysis.BMC pharmacology & toxicology · 2024Pooled it
- Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.Frontiers in pharmacology · 2024Pooled it
- Atezolizumab plus cabozantinib versus cabozantinib monotherapy for patients with renal cell carcinoma after progression with previous immune checkpoint inhibitor treatment (CONTACT-03): a multicentre, randomised, open-label, phase 3 trial.Lancet (London, England) · 2023Trial
- Trial
- Farnesyl Transferase Inhibitor KO-2806 (Darlifarnib) Enhances the Antitumor Activity of Tyrosine Kinase Inhibitors in RCC.Molecular cancer therapeutics · 2026Article
- Review
- Navigating Recurrence in Clear Cell Renal Cell Carcinoma after Adjuvant Immunotherapy.Journal of kidney cancer and VHL · 2026Review
- When Effective Therapies Collide: Aorto-Esophageal Fistula After Thoracic Radiotherapy and Anti-VEGF TKI in a Long-Survivor with mRCC.Journal of kidney cancer and VHL · 2026Article
- Article
- Real-life Use of Cabozantinib in Front-line therapy for Metastatic Renal Cell Carcinoma: The CabFRONT Study (Meet-URO 24).European urology open science · 2025Article
- Second-Line Systemic Therapies in Metastatic Renal Cell Carcinoma: Current Insights and Future Directions.Journal of cancer immunology · 2025Article
- Real-World Oncological Outcomes of Nivolumab Plus Ipilimumab in Advanced or Metastatic Renal Cell Carcinoma: A Multicenter, Retrospective Cohort Study in Japan.Current oncology (Toronto, Ont.) · 2024Article
- Novel Immune Checkpoint Inhibitor Targets in Advanced or Metastatic Renal Cell Carcinoma: State of the Art and Future Perspectives.Journal of clinical medicine · 2024Review
- Management of Metastatic Renal Cell Carcinoma Following First-Line Immune Checkpoint Therapy Failure: A Systematic Review.Cancers · 2024Review
- Efficacy and Safety of Immuno-Oncology Plus Tyrosine Kinase Inhibitors as Late-Line Combination Therapy for Patients with Advanced Renal Cell Carcinoma.Journal of clinical medicine · 2024Article
- The efficacy of subsequent therapy after failure of anti-PD-1 antibody in metastatic renal cell carcinoma.Translational cancer research · 2024Article
- Analysis of Factors Contributing to Adverse Events and Evaluation of Their Impact on Prognosis in Metastatic Renal Cell Carcinoma Patients-Real-World Experience in a Single-Center Retrospective Study and Narrative Review.Medicina (Kaunas, Lithuania) · 2024Review
- Research Progress of PD 1/PD L1 Inhibitors in the Treatment of Urological Tumors.Current cancer drug targets · 2024Review
- Endothelial cells in tumor microenvironment: insights and perspectives.Frontiers in immunology · 2024Review
- Impressive and Prolonged Response with Lenvatinib in a Highly Pretreated Patient with Metastatic Clear Cell Renal Cancer: A Case Report.Journal of kidney cancer and VHL · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 16 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFirst-line therapies based on immune-checkpoint inhibitors (ICIs) significantly improved survival of metastatic renal cell carcinoma (mRCC) patients. Cabozantinib was shown to target kinases involved in immune-escape and to prolong survival in patients pre-treated with tyrosine-kinase-inhibitors (TKIs). The impact of ICIs combinations in first line on subsequent therapies is still unclear.
methodsThis is an open label, multicenter, single arm, phase II study designed to assess activity, safety and efficacy of cabozantinib in mRCC patients progressed after an adjuvant or first line anti-Programmed Death (PD)-1/PD-Ligand (PD-L) 1-based therapy. Primary endpoint was progression free survival (PFS), secondary endpoints were overall survival (OS), objective response rate (ORR) and safety.
results31 patients were included in the analysis. After a median (m) follow-up of 11.9 months, mPFS was 8.3 months (90%CI 3.9-17.4) and mOS was 13.8 months (95%CI 7.7-29.0). ORR was 37.9% with an additional 13 patients achieving disease stability. Grade 3-4 adverse events occurred in 47% of patients, including more frequently creatine phosphokinase (CPK) serum level elevation, neutropenia, hyponatremia, diarrhea, hand-food syndrome, oral mucositis and hypertension.
conclusionsThe BREAKPOINT trial met its primary endpoint showing that cabozantinib as second line therapy after ICIs was active in mRCC. Safety profile was manageable. TRIAL REGISTRATION NUMBER: NCT03463681 - A Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma (BREAKPOINT) - https://clinicaltrials.gov/ct2/show/NCT03463681.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.