Trial reportJournal for immunotherapy of cancer2018
A multi-center phase II study of high dose interleukin-2 sequenced with vemurafenib in patients with BRAF-V600 mutation positive metastatic melanoma.
Trial report in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01683188 (A Multi-Center Study of High Dose Aldesleukin), which is not on this map. Cited by 13 papers.
What it found
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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 Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive Metastatic Melanoma
Who cites it
13 citing papers in PubMed, 17 citations in OpenAlex.
- Radiotherapy and High-Dose Interleukin-2: Clinical and Immunological Results of a Proof of Principle Study in Metastatic Melanoma and Renal Cell Carcinoma.Frontiers in immunology · 2021Trial
- Melanoma: Pathogenesis and Targeted Therapy.MedComm · 2026Review
- The future of targeted kinase inhibitors in melanoma.Pharmacology & therapeutics · 2022Review
- Signal pathways of melanoma and targeted therapy.Signal transduction and targeted therapy · 2021Review
- The role of NLRP3 in the prognosis and immune infiltrates of skin cutaneous melanoma (SKCM).Translational cancer research · 2021Article
- Clinical Implications of Acquired BRAF Inhibitors Resistance in Melanoma.International journal of molecular sciences · 2020Review
- The non-linearity of RAF-MEK signaling in dendritic cells.Cell cycle (Georgetown, Tex.) · 2020Review
- The potential of BRAF-targeted therapy combined with immunotherapy in melanoma.Expert review of anticancer therapy · 2020Review
- Review
- Gene expression and promoter methylation of angiogenic and lymphangiogenic factors as prognostic markers in melanoma.Molecular oncology · 2019Article
- Therapy with high-dose Interleukin-2 (HD IL-2) in metastatic melanoma and renal cell carcinoma following PD1 or PDL1 inhibition.Journal for immunotherapy of cancer · 2019Article
- Combination of Immunotherapy With Targeted Therapy: Theory and Practice in Metastatic Melanoma.Frontiers in immunology · 2019Review
- Combined targeted therapy and immunotherapy in melanoma: a review of the impact on the tumor microenvironment and outcomes of early clinical trials.Therapeutic advances in medical oncology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 14 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreclinical studies suggest that BRAF inhibitors enhance anti-tumor immunity and antigen presentation. Combination BRAF inhibition with immunotherapy is an appealing therapeutic approach. We sequenced vemurafenib with HD IL-2 in patients with BRAF-mutated metastatic melanoma to improve long term outcomes.
methodsEligible patients were HD IL-2 eligible with metastatic BRAF V600 mutated melanoma. Cohort 1 was treatment naïve and received vemurafenib 960 mg BID for 6 weeks before HD IL-2. Cohort 2 received vemurafenib for 7-18 weeks before enrollment. Both cohorts received HD IL-2 at 600,000 IU/kg every 8 h days 1-5 and days 15-19. The primary objective was to assess complete responses (CR) at 10 weeks ±3 (assessment 1) and 26 weeks ±3 (assessment 2) from the start of HD IL-2.
resultsFifty-three patients were enrolled, (cohort 1, n = 38; cohort 2, n = 15). Of these, 39 underwent assessment 1 and 15 assessment 2. The CR rate at assessment 1 was 10% (95% CI 3-24) for both cohorts combined, and 27% (95% CI 8-55) at assessment 2. Three-year survival was 30 and 27% for cohort 1 and cohort 2, respectively. No unexpected toxicities occurred. A shift in the melanoma treatment landscape during this trial adversely affected accrual, leading to early trial closure.
conclusionsVemurafenib in sequence with HD IL-2 did not change the known toxicity profile for either agent. Lower than expected response rates to vemurafenib were observed. Overall response rates and durability of responses appear similar to that observed with HD IL-2 alone.
trial registrationNCTN, NCT01683188. Registered 11 September 2012, http://www.clinicaltrials.gov/NCT01683188.
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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.