SNPMiner Trials (Home Page)
Report for Clinical Trial NCT03228667
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies
in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint
inhibitors. All patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1
checkpoint inhibitor plus N-803 for up to 17 cycles. Each cycle is six weeks in duration.
Some patients who experience disease progression while on study in Cohorts 1-4 may roll over
into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N-803,
and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks
in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive
the same checkpoint inhibitor that they received during their previous therapy. Radiologic
evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2
years, or until the patient experiences confirmed progressive disease or unacceptable
toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's
best interest to continue treatment. Patients will be followed for disease progression,
post-therapies, and survival through 24 months past administration of the first dose of study
drug.
Name: N-803 + Pembrolizumab
Description: Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 4 Cohort 1 Cohort 2 Cohort 3 Cohort 4
Name: N-803 + Nivolumab
Description: Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 4 Cohort 1 Cohort 2 Cohort 3 Cohort 4
Name: N-803 + Atezolizumab
Description: Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2 Cohort 1 Cohort 4
Name: N-803 + Avelumab
Description: Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2 Cohort 1 Cohort 4
Name: N-803 + Durvalumab
Description: Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2 Cohort 1 Cohort 4
Name: N-803 + Pembrolizumab + PD-L1 t-haNK
Description: Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
Type: Drug
Name: N-803 + Nivolumab + PD-L1 t-haNK
Description: Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
Type: Drug
Name: N-803 + Atezolizumab + PD-L1 t-haNK
Description: Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
Type: Drug
Name: N-803 + Avelumab + PD-L1 t-haNK
Description: Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
Type: Drug
Name: N-803 + Durvalumab + PD-L1 t-haNK
Description: Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
Type: Drug
Primary Outcomes
Description: Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Measure: Objective Response Rate
Time: 24 months
Secondary Outcomes
Description: Assess time from first treatment to death resulting from cancer.
Measure: Disease-specific Survival
Time: 24 months
Description: Assess time from first treatment to death resulting from any cause.
Measure: Overall Survival
Time: 24 months
Description: Assess time to response
Measure: Time to Response
Time: 24 months
Description: Assess duration of response
Measure: Duration of Response
Time: 24 months
Description: Assess incidence of adverse events.
Measure: Incidence of Adverse Events
Time: 24 months
Description: Compare changes in QOL scores from baseline.
Measure: Quality of Life (QOL)
Time: 24 months
Description: Assess time from first treatment to disease progression or death from any cause, whichever occurs first.
Measure: Progression Free Survival
Time: 24 months
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 V600E
Patients with BRAF V600E mutation-positive melanoma were
not required to have received prior BRAF inhibitor therapy; OR unresectable
or metastatic melanoma with progression, refractory to ≥ 2 doses of
ipilimumab (3 mg/kg or higher) and, if BRAF V600 mutation-positive, a BRAF
or MEK inhibitor, and disease progression within 24 weeks following the last
dose of ipilimumab. --- V600E ---