Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02631447
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2015-12-09
Brief Title:
Sequential Combo Immuno and Target Therapy SECOMBIT Study
Sponsor:
Fondazione Melanoma Onlus
Organization:
Fondazione Melanoma Onlus
Study Overview
Official Title:
A Three Arms Prospective Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy IpilimumabNivolumab and Combo Target Therapy LGX818MEK162 in Patients With Metastatic Melanoma and BRAF Mutation
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECOMBIT
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 94 months versus 54 and 58 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 mgkg and nivolumab 1 mgkg 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 inhibitorsipilimumab 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
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 mgkg and nivolumab 1 mgkg 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 inhibitorsipilimumab 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004842-92 | EUDRACT_NUMBER | None | None |