SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03840915

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

NCT03840915 Carcinoma, Non-Small-Cell Lung
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

10 Interventions

Name: Cisplatin

Description: Cisplatin will be administered intravenously at a dose of 75 milligrams per meter square (mg/m^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824

Name: Carboplatin

Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824

Name: Pemetrexed

Description: Pemetrexed will be administered intravenously at a dose of 500 mg/ m^2 over 10 minutes every 21 days.

Type: Drug

Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824

Name: Nab-paclitaxel

Description: Nab-paclitaxel will be administered intravenously at as dose of 100 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort B: Carboplatin + Nab-paclitaxel + M7824

Name: Gemcitabine

Description: Gemcitabine will be administered intravenously at a dose of 1250 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824

Name: Docetaxel

Description: Docetaxel will be administered intravenously at a dose of 75 mg/m^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort D: Docetaxel + M7824

Name: M7824

Description: M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed.

Type: Drug

Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824

Name: Carboplatin

Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort B: Carboplatin + Nab-paclitaxel + M7824

Name: Carboplatin

Description: Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).

Type: Drug

Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824

Name: M7824

Description: M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone.

Type: Drug

Cohort B: Carboplatin + Nab-paclitaxel + M7824 Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 Cohort D: Docetaxel + M7824


Primary Outcomes

Measure: Incidence of Dose Limiting Toxicities (DLTs)

Time: Day 1 to Day 21 (Cycle 1)

Measure: Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events

Time: Up to 3 years

Secondary Outcomes

Measure: Confirmed Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1

Time: Up to 3 years

Measure: Progression-Free Survival (PFS) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1

Time: Up to 3 years

Measure: Overall Survival (OS)

Time: Up to 3 years

Measure: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1

Time: Up to 3 years

Measure: Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi)

Time: Up to 3 years

Measure: Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough)

Time: Up to 3 years

Measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M7824

Time: Up to 3 years

Measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824

Time: Up to 3 years

Measure: Maximum Observed Serum Concentration (Cmax) of M7824

Time: Up to 3 years

Measure: Time to Reach Maximum Serum Concentration (Tmax) of M7824

Time: Up to 3 years

Measure: Apparent Terminal Half-life (t1/2) of M7824

Time: Up to 3 years

Measure: Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay

Time: Up to 3 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Fresh biopsies should be collected if archived tumor material is not available - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry and date of first dose Exclusion Criteria: - The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved - Mixed small cell with non-small cell lung cancer histology - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6 months prior to the first dose of study intervention - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. --- V600E ---



HPO Nodes


HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1