Evaluate Efficacy of Avelumab, haNK and N-803 in Subjects With Progressed MCC on or After Checkpoint Inhibitor Therapy.
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|ClinicalTrials.gov Identifier: NCT03853317|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma||Biological: Avelumab Biological: N-803 Biological: haNK™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Combination Therapy With an IL-15 Superagonist (N-803), Off-the-shelf CD16-targeted Natural Killer Cells (haNK), and Avelumab Without Cytotoxic Chemotherapy in Subjects With Merkel Cell Carcinoma (MCC) That Has Progressed on or After Treatment With a Checkpoint Inhibitor|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: Treatment with avelumab, haNK™ and N-803
The primary objective is to determine the efficacy of the combination treatment of avelumab, haNK, and N-803 in subjects with MCC that has progressed on or after checkpoint inhibitor therapy by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on Blinded Independent Central Review (BICR).
For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
Other Name: (BAVENCIO® injection, for intravenous [IV] use)
Recombinant human super agonist interleukin-15 (IL-15) complex
Other Name: also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex]), ALT-803
haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
Other Name: NK-92 [CD16.158V, ER IL-2], (haNK™ for Infusion)
- Overall Response Rate (ORR) [ Time Frame: 24 Months ]Defined by RECIST 1.1 based on BICR.
- Overall Response Rate (ORR) [ Time Frame: 24 Months ]Defined by RECIST Version 1.1 based on BICR.
- Duration of Response (DOR) [ Time Frame: 24 Months ]Defined by RECIST Version 1.1 based on BICR.
- PFS [ Time Frame: 24 Months ]Defined by RECIST Version 1.1 and irRECIST based on BICR.
- Overall Survival (OS) [ Time Frame: 24 Months ]Graded using CTCAE Version 5.0.
- Disease-Specific Survival (DSS) [ Time Frame: 24 Months ]Analyzed using Kaplan-Meier Methods.
- Disease Control Rate (DCR) [ Time Frame: 2 Months ]Confirmed CR, PR, or stable disease [SD] lasting for greater than 2 months, by RECIST Version 1.1 and irRECIST by BICR.
- Quality of Life Questionnaire [ Time Frame: 24 Months ]Conducted via PROs using the Functional Assessment of Cancer Therapy-Melanoma (FACT-M)
- Incidence of treatment-emergent AEs and SAEs [ Time Frame: 24 Months ]Graded using the NCI CTCAE Version 5.0
- Immunogenicity profile of N-803 in combination with avelumab and haNK [ Time Frame: 24 Months ]Detection of anti-drug antibodies.
- Pharmacokinetic profile of N-803 in combination with avelumab and haNK [ Time Frame: 24 Months ]Maximum observed concentration (Cmax)
- Tumor molecular profiles and correlations with subject outcomes [ Time Frame: 9 weeks ]Genomic sequencing of tumor cells from tissue.
- Molecular changes in ctDNA and ctRNA and correlations with subject outcomes. [ Time Frame: 24 Months. ]Expression levels of specific tumor- and immune-related analytes in ctDNA and ctRNA will be measured by qPCR
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): NCT03853317
|Contact: Amy Rock, PhDfirstname.lastname@example.org|
|Contact: Erika Monty, BSemail@example.com|
|United States, California|
|Chan Soon-Shiong Institute for Medicine||Not yet recruiting|
|El Segundo, California, United States, 90245|
|Contact: Clinical Trials Navigator firstname.lastname@example.org|
|Study Chair:||John Lee, MD||NantKwest, Inc.|