Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2013
Clinical activity and safety of combination therapy with temsirolimus and bevacizumab for advanced melanoma: a phase II trial (CTEP 7190/Mel47).
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00397982 (A Phase II Study of CCI-779 in Combination With Bevacizumab in Stage III or IV Melanoma), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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 Phase II Study of CCI-779 in Combination With Bevacizumab in Stage III or IV Melanoma
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Efficacy and safety of bevacizumab in patients with malignant melanoma: a systematic review and PRISMA-compliant meta-analysis of randomized controlled trials and non-comparative clinical studies.Frontiers in pharmacology · 2023Pooled it
- A phase II study evaluating the toxicity and efficacy of single-agent temsirolimus in chemotherapy-naïve castration-resistant prostate cancer.British journal of cancer · 2013Trial
- Advancements in Melanoma Therapies: From Surgery to Immunotherapy.Current treatment options in oncology · 2024Review
- Review
- Advances in targeted therapy and immunotherapy for melanoma (Review).Experimental and therapeutic medicine · 2023Review
- Molecular Markers and Targets in Melanoma.Cells · 2021Review
- Defining best practices for tissue procurement in immuno-oncology clinical trials: consensus statement from the Society for Immunotherapy of Cancer Surgery Committee.Journal for immunotherapy of cancer · 2020Review
- Non-BRAF Mutant Melanoma: Molecular Features and Therapeutical Implications.Frontiers in molecular biosciences · 2020Review
- Bevacizumab as a steroid-sparing agent during immunotherapy for melanoma brain metastases: A case series.Health science reports · 2019Article
- Treatment ofTherapeutic advances in medical oncology · 2017Review
- Towards combinatorial targeted therapy in melanoma: from pre-clinical evidence to clinical application (review).International journal of oncology · 2014Review
- BRAF and beyond: Tailoring strategies for the individual melanoma patient.Journal of carcinogenesis · 2014Review
- Management of hyperhidrosis.Clinical, cosmetic and investigational dermatology · 2014Review
- MicroRNAs induced in melanoma treated with combination targeted therapy of Temsirolimus and Bevacizumab.Journal of translational medicine · 2013Article
- Recent advances in melanoma treatment - American Society of Clinical Oncology (ASCO) 2012 perspective.Contemporary oncology (Poznan, Poland) · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 4 institutions in 1 country.
Funding
Abstract
purposeA CTEP-sponsored phase II trial was conducted to evaluate safety and clinical activity of combination therapy with CCI-779 (temsirolimus) and bevacizumab in patients with advanced melanoma. EXPERIMENTAL
designPatients with unresectable stage III to IV melanoma were treated intravenously with temsirolimus 25 mg weekly and bevacizumab 10 mg every 2 weeks. Adverse events were recorded using CTCAE v3.0. Tumor response was assessed by Response Evaluation Criteria in Solid Tumors and overall survival was recorded. Correlative studies measured protein kinases and histology of tumor biopsies and immune function in peripheral blood.
resultsSeventeen patients were treated. Most patients tolerated treatment well, but 2 had grade 4 lymphopenia and 1 developed reversible grade 2 leukoencephalopathy. Best clinical response was partial response (PR) in 3 patients [17.7%, 90% confidence interval (CI) 5, 0-39.6], stable disease at 8 weeks (SD) in 9 patients, progressive disease (PD) in 4 patients, and not evaluable in 1 patient. Maximal response duration for PR was 35 months. Ten evaluable patients had BRAF(WT) tumors, among whom 3 had PRs, 5 had SD, and 2 had PD. Correlative studies of tumor biopsies revealed decreased phospho-S6K (d2 and d23 vs. d1, P < 0.001), and decreased mitotic rate (Ki67(+)) among melanoma cells by d23 (P = 0.007). Effects on immune functions were mixed, with decreased alloreactive T-cell responses and decreased circulating CD4(+)FoxP3(+) cells.
conclusionThese data provide preliminary evidence for clinical activity of combination therapy with temsirolimus and bevacizumab, which may be greater in patients with BRAF(wt) melanoma. Mixed effects on immunologic function also support combination with immune therapies.
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What OpenQuestion holds
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.