SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03711058

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I/II Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.

NCT03711058 Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor Along With Microsatellite Stable (MSS) Colon Cancer Colon Cancer
MeSH: Colorectal Neoplasms Colonic Neoplasms
HPO: Colon cancer Neoplasm of the colon Neoplasm of the large intestine

2 Interventions

Name: Copanlisib

Description: Copanlisib will be administered as a 60 minute IV infusion (-5min/+10min) at a dose of 45 mg - 60 mg IV. Copanlisib will be administered once a week (days 1, 8, and 15 or Day 1 and Day 15 of each 28 day cycle). Drug: 45 or 60 mg IV

Type: Drug

Phase I - Copanlisib and Nivolumab (De-Escalation) Phase II - Copanlisib and Nivolumab

Name: Nivolumab

Description: Nivolumab 480 mg will be administered as a 60 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle. Drug: 480 mg IV

Type: Drug

Phase I - Copanlisib and Nivolumab (De-Escalation) Phase II - Copanlisib and Nivolumab


Primary Outcomes

Description: Number of patients having a dose limiting toxicities (DLT) at each level.

Measure: Determine maximum tolerated dose (MTD) of copanlisib with fixed dose nivolumab

Time: 2 years

Description: The proportion of subjects with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Measure: 6-month objective response rate (ORR) of patients treated with copanlisib and nivolumab

Time: 6-months

Secondary Outcomes

Description: Percentage of participants achieving stable disease (SD) or better (SD + partial response (PR) + (CR).

Measure: Disease control rate (DCR) status at 6 months.

Time: 6-months

Description: Number of months from the first documentation of a response to date of disease progression.

Measure: Duration of response (DOR) status at 6 months.

Time: 6-months

Description: Number of months from treatment to disease progression (PD)

Measure: Progression free survival (PFS) status at 6 months.

Time: 6-months

Description: Number of months from the date of first treatment until death or end of follow-up.

Measure: Overall survival (OS) status at 6 months.

Time: 6-months

Description: Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.

Measure: Number of participants experiencing study drug-related toxicities

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 P13K

- Prior therapy with a P13K inhibitor - Chemotherapy, radiotherapy, investigational therapy, or surgery within 4 weeks prior to first dose of treatment. --- P13K ---



HPO Nodes


HPO:
Colon cancer
Genes 39
FOXE1 PMS1 APC MLH1 CDKN2A KRAS PRKAR1A FLCN TGFBR2 MSH6 COL14A1 RPS19 BMPR1A HABP2 PMS2 MSH2 MSH3 MLH3 GREM1 MINPP1 BRCA1 BUB3 BRCA2 CEP57 AAGAB TRIP13 EPCAM PIK3CA PALLD NTHL1 PALB2 MUTYH TP53 AXIN2 SMAD4 BUB1 SH3KBP1 BUB1B FAN1
Neoplasm of the colon
Genes 54
FOXE1 PMS1 CDKN2A KRAS TGFBR2 STK11 MSH6 BMPR1A PMS2 MLH3 BRCA1 BRCA2 PDGFRA PIK3CA POLD1 NTHL1 POLE BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 RPS19 RPS20 HABP2 MSH2 MSH3 GREM1 MINPP1 SEMA4A BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM RNF43 PALLD PALB2 MUTYH SDHA TP53 SDHB SDHC AXIN2 SMAD4 FAN1
Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1