SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT03228667

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients Who Have Disease Progression Following an Initial Response to Treatment With PD-1/PD-L1 Checkpoint Inhibitor Therapy

This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803 in combination with an FDA-approved PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitor therapy. All patients will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each cycle is six weeks in duration. All patients will receive ALT-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.

NCT03228667 Non-Small Cell Lung Cancer Small Cell Lung Cancer Urothelial Carcinoma Head and Neck Squamous Cell Carcinoma Merkel Cell Carcinoma Melanoma Renal Cell Carcinoma Gastric Cancer Cervical Cancer Hepatocellular Carcinoma Microsatellite Instability Mismatch Repair Deficiency Colorectal Cancer
MeSH:Carcinoma, Merkel Cell Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Melanoma Colorectal Neoplasms Carcinoma, Squamous Cell Carcinoma, Hepatocellular Stomach Neoplasms Uterine Cervical Neoplasms Carcinoma, Renal Cell Small Cell Lung Carcinoma Carcinoma, Transitional Cell Squamous Cell Carcinoma of Head and Neck Microsatellite Instability
HPO:Carcinoma Cervical polyp Cervix cancer Clear cell renal cell carcinoma Cutaneous melanoma Hepatocellular carcinoma Melanoma Merkel cell skin cancer Neoplasm of the large intestine Neoplasm of the lung Neoplasm of the stomach Non-small cell lung carcinoma Papillary renal cell carcinoma Renal cell carcinoma Small cell lung carcinoma Squamous cell carcinoma

4 Interventions

Name: ALT-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 ALT-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 5

Coho Cohort 1 Cohort 2 Cohort 3 Cohort 4

Name: ALT-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 ALT-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2

Cohort 1 Cohort 4

Name: ALT-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 ALT-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2

Cohort 1 Cohort 4

Name: ALT-803 + Avelumab

Description: Patients will receive 10 mg/kg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks.
Type: Drug
Group Labels: 2

Cohort 1 Cohort 4


Primary Outcomes

Description: Assess the anti-tumor activity of ALT-803 in combination with a PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitors.

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 amount of time disease does not get worse after first treatment.

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 ---



HPO Nodes


HPO:
Protein Mutations 0
SNP 0