Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT04493203|
Recruitment Status : Suspended (Study to resume after FDA review)
First Posted : July 30, 2020
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma Unresectable Melanoma||Drug: Nivolumab Drug: Axitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||August 2025|
Experimental: Nivolumab plus Axitinib
Nivolumab 480mg, IV, every 4 weeks, for up to two years.
Axitinib 5mg, PO, BID, for up to two years.
Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)
Other Name: INLYTA
- Overall Response Rate (ORR) [ Time Frame: Up to 12 weeks from baseline (after treatment) ]Overall response rate (ORR) will be estimated by the percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
- Serious Adverse Events Possibly, Probably or Definitely Related to Study Treatment [ Time Frame: Up to 28 days after discontinuation of study treatment ]Frequency of patients experiencing Serious Adverse Events determined to be possibly, probably or definitely related to study treatment using a Bayesian monitoring scheme to continuously monitor the rate of severe adverse events (SAE). SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Toxicity events will evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).
- Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]Progression-free survival is the time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
- Overall Survival (OS) [ Time Frame: Up to 5 years ]The length of time from the start of treatment that patients remain alive, until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493203
|United States, Pennsylvania|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Yana Najjar, MD||UPMC Hillman Cancer Center|