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Spots Global Cancer Trial Database for Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

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Trial Identification

Brief Title: Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

Official Title: A Three Arms Prospective, Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy (Ipilimumab/Nivolumab) and Combo Target Therapy (LGX818/MEK162) in Patients With Metastatic Melanoma and BRAF Mutation

Study ID: NCT02631447

Study Description

Brief Summary: To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation.

Detailed Description: The combination BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor plus mitogen-activated protein kinase (MEK) inhibitor seems to be more effective in the V600 BRAF mutated advanced melanoma patients compared to treatment with the BRAF inhibitors alone. In fact, a phase I-II study showed a better overall response rate (ORR) and progression-free survival (PFS) in the combination arm (dabrafenib plus trametinib) respect to the single agent treatment (dabrafenib): 76% and 9.4 months versus 54% and 5.8 months respectively. Another phase I study with a similar combination (vemurafenib plus cobimetinib) showed an ORR of 85% in vemurafenib-naïve patients. Recently, the results of a phase I study about the combination ipilimumab plus nivolumab have been reported. In this study at the selected schedule (ipilimumab 3 mg/kg and nivolumab 1 mg/kg), 53% of patients had an objective response, all with tumor reduction of 80% or more. Reponses were durable, although longer follow-up is needed. A recent phase I study has shown a high rate of liver toxicity with the combo ipilimumab plus vemurafenib . which makes difficult a combination with these two different drugs. Moreover, a better efficacy of the sequencing treatment BRAF inhibitors/ipilimumab vs. the single agent treatment was also observed; for this reason it was also suggested to start immunotherapy treatment in the BRAF V600 mutated melanoma population as first option, in order to increase the percentage of patients who can benefit from the sequencing, considering the possibility of a fast progression of the disease after the BRAF inhibitors treatment. Taking into account these considerations, it seems impossible to think to combine all the four compounds (the target agents and immunomodulating monoclonal antibodies). The risk of a high rate of toxicity is realistic and would render this approach inapplicable. Sequencing with these different combinations seems to be more feasible. However, also in this case it would be important to start with the best combination in order to give to the patients the best chance to increase the overall survival. The aim of this prospective randomized phase II study is to evaluate the sequencing of these two different combinations and evaluate which is the best of these approaches.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Paracelsus Medical University, Salzburg, AT, Austria

Karl Landsteiner University of Health Sciencies - University Clinic, St. Pölten, AT, Austria

Medical University of Graz, Graz, AU, Austria

Medical University of Vienna, Wien, , Austria

Hôpitaux Universitaires Saint-Louis, Paris, , France

University of Tuebingen, Tuebingen, , Germany

University of Athens, Athens, , Greece

IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l., Meldola, Forlì-Cesena, Italy

National Institute of Cancer, Bari, , Italy

Università degli Studi di Bari Aldo Moro, Bari, , Italy

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy

IRCCS San Martino - IST, Genova, , Italy

Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori, Milano, , Italy

IEO - Istituto Europeo di Oncologia - IRCCS, Milano, , Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale", Naples, , Italy

Azienda Ospedaliero Universitaria Federico II, Naples, , Italy

Istituto Oncologico Veneto, Padova, , Italy

Istituto Nazionale Tumori Regina Elena, Roma, , Italy

Istituto Dermopatico dell'Immacolata - IDI - IRCCS, Roma, , Italy

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

Azienda Ospedaliera Universitaria - Città della Salute e della Scienza di Torino, Torino, , Italy

Azienda Ospedaliera Universitaria Integrata di Udine, Udine, , Italy

Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, PL, Poland

Hospital Universitario Quiròn Dexeus, Barcelona, SP, Spain

Hospital Clínic Barcelona, Barcelona, , Spain

Clinica Universidad de Navarra, Pamplona, , Spain

Karolinska University Hospital, Stockholm, , Sweden

University Hospital Zurich, Zurich, , Switzerland

The Royal Marsden NHS Foundation Trust, London, , United Kingdom

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Contact Details

Name: Paolo Ascierto, MD

Affiliation: Fondazione Melanoma Onlus

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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