SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03111901

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Low-dose Interleukin-2 and Pembrolizumab Among Patients With Metastatic Melanoma and Renal Cell Carcinoma

This study will evaluate the safety and disease control rate of the combination of pembrolizumab plus low-dose interleukin-2 in patients who have either advanced melanoma or renal cell cancer.

NCT03111901 Carcinoma, Renal Cell Melanoma
MeSH:Carcinoma Melanoma Carcinoma, Renal Cell
HPO:Carcinoma Clear cell renal cell carcinoma Cutaneous melanoma Melanoma Papillary renal cell carcinoma Renal cell carcinoma

2 Interventions

Name: Pembrolizumab

Description: Pembrolizumab solution
Type: Drug
Group Labels: 2

Level -1 Level 1

Name: Interleukin-2

Description: Interleukin-2 solution
Type: Drug
Group Labels: 2

Level -1 Level 1


Primary Outcomes

Description: Obtain preliminary data on the safety of LD-IL2 with pembrolizumab

Measure: Safety: adverse event profile

Time: up to 90 days post-treatment

Description: Estimate the disease control rate (CR+PR+SD by RECIST 1.1) among candidate patients with metastatic melanoma treated with pembrolizumab and LD-IL2 and to determine whether disease control is significantly improved. SD for 6 months or more will be considered SD for the purpose of this assessment.

Measure: Disease control rate: melanoma

Time: baseline and every 9 weeks (up to week 104)

Description: Estimate the disease control rate (CR+PR+SD by RECIST 1.1) among patients with metastatic renal cell cancer treated with pembrolizumab and LD-IL2 and to determine whether disease control is significantly improved. SD for 6 months or more will be considered SD for the purpose of this assessment.

Measure: Disease control rate: renal cell cancer

Time: baseline and every 9 weeks (up to week 104)

Secondary Outcomes

Description: Estimate progression-free survival defined as the duration of time from first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first

Measure: Progression free survival: metastatic melanoma

Time: From first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first, assessed for an estimated total of 120 months.

Description: Estimate progression-free survival defined as the duration of time from first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first

Measure: Progression free survival: renal cell cancer

Time: From first response (SD/PR/CR) to time of recurrence/progression or death from any cause, whichever occurs first, assessed for an estimated total of 120 months.

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There are 3 SNPs

SNPs


1 V600E

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E ---


2 V600K

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E --- --- V600K ---


3 V600R

If the melanoma expresses a BRAF mutation of V600E, V600K, or V600R patient must have received and progressed through a BRAF inhibitor or have failed that therapy due to toxicity. --- V600E --- --- V600K --- --- V600R ---



HPO Nodes


HPO: