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Report for Clinical Trial NCT03207867

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

NCT03207867 NSCLC, Non Small Cell Lung Cancer RCC, Renal Cell Cancer Pancreatic Cancer Urothelial Cancer Head and Neck Cancer DLBCL, Diffused Large B Cell Lymphoma MSS, Microsatellite Stable Colon Cancer TNBC, Triple Negative Breast Cancer Melanoma
MeSH:Lymphoma Lymphoma, Non-Hodgkin Triple Negative Breast Neoplasms Carcinoma, Renal Cell
HPO:Clear cell renal cell carcinoma Lymphoma Non-Hodgkin lymphoma Papillary renal cell carcinoma Renal cell carcinoma

2 Interventions

Name: NIR178

Description: NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.
Type: Drug
Group Labels: 4

Japanese safety run-in part NIR178 + PDR001 NIR178 BID Intermittent + PDR001 Part 3

Name: PDR001

Description: PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle
Type: Drug
Group Labels: 4

Japanese safety run-in part NIR178 + PDR001 NIR178 BID Intermittent + PDR001 Part 3


Primary Outcomes

Description: Response assessed by RECIST v1.1 (for solid tumors) or Cheson (for DLBCL)

Measure: Determine the overall response rate

Time: Every 8 weeks for first 40 weeks

Description: Response assessed by RECIST v1.1 (for solid tumors) or Cheson (for DLBCL)

Measure: Determine the overall response rate

Time: Every 12 weeks after the first 40 weeks until disease progression or study discontinuation (an average of 6 months)

Description: Response assessed by RECIST v1.1 (for solid tumors) or Cheson (for DLBCL)

Measure: Determine the overall response rate

Time: Baseline

Secondary Outcomes

Description: Proportion of patients with a best overall response of CR or PR or SD

Measure: Determine the disease control rate (DCR)

Time: Baseline

Description: Time from first documented response to disease progression

Measure: Determine the duration of response (DoR)

Time: Baseline

Description: Time from start of treatment to date of death due to any reason

Measure: Determine the overall survival rate (OR)

Time: Every 12 weeks until end of study for at least 24 months from the start date of the study treatment

Description: Time from start of treatment to date of the first documented progression or death in months

Measure: Progression free survival (PFS)

Time: Baseline

Description: Type, frequency, and severity of AEs and SAEs; Frequency of dose interruptions, reductions and discontinuation, Dose intensity

Measure: Safety and tolerability of the NIR178 and PDR001 combination

Time: Date of consent to end of study (An average of 24 months)

Description: Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8)

Measure: Characterize changes in the immune infiltrate in tumors

Time: Screening

Description: Presence and/or concentration of anti-PDR001 antibodies

Measure: Presence and/or concentration of anti-PDR001 antibodies

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of NIR178 and its metabolites

Measure: Pharmacokinetics: Area under plasma concentration versus time curve (AUC) (NIR178)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of PDR001

Measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (PDR001)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of NIR178

Measure: Plasma concentration Vs Time profiles (NIR178)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of PDR001

Measure: Plasma concentration Vs Time profiles (PDR001)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of NIR178

Measure: Peak plasma concentration- Cmax (NIR178)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of PDR001

Measure: Peak plasma concentration- Cmax (PDR001)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of NIR178

Measure: Time of maximum concentration observed- Tmax (NIR178)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of PDR001

Measure: Time of maximum concentration observed- Tmax (PDR001)

Time: End of treatment and as needed (an average of 6 months)

Description: Proportion of patients with a best overall response of CR or PR or SD

Measure: Determine the disease control rate (DCR)

Time: Every 8 weeks for first 40 weeks

Description: Proportion of patients with a best overall response of CR or PR or SD

Measure: Determine the disease control rate (DCR)

Time: Every 12 weeks after the first 40 weeks until disease progression

Description: Time from first documented response to disease progression

Measure: Determine the duration of response (DoR)

Time: Until study discontinuation (an average of 6 months)

Description: Time from first documented response to disease progression

Measure: Determine the duration of response (DoR)

Time: Every 8 weeks for first 40 weeks

Description: Time from start of treatment to date of the first documented progression or death in months

Measure: Progression free survival (PFS)

Time: Until study discontinuation (an average of 6 months)

Description: Time from start of treatment to date of the first documented progression or death in months

Measure: Progression free survival (PFS)

Time: Every 8 weeks for first 40 weeks

Description: Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8)

Measure: Characterize changes in the immune infiltrate in tumors

Time: Cycle 6 Day 1

Description: Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8)

Measure: Characterize changes in the immune infiltrate in tumors

Time: Cycle 1 Day 8

Description: Change from baseline in TILs by immunohistochemistry (IHC) (such as CD8)

Measure: Characterize changes in the immune infiltrate in tumors

Time: Cycle 3 Day 1

Description: Presence and/or concentration of anti-PDR001 antibodies

Measure: Presence and/or concentration of anti-PDR001 antibodies

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of NIR178 and its metabolites

Measure: Pharmacokinetics: Area under plasma concentration versus time curve (AUC) (NIR178)

Time: End of treatment and as needed (an average of 6 months)

Description: Plasma concentration time profiles of NIR178

Measure: Plasma concentration Vs Time profiles (NIR178)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of PDR001

Measure: Plasma concentration Vs Time profiles (PDR001)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of NIR178

Measure: Peak plasma concentration- Cmax (NIR178)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of PDR001

Measure: Peak plasma concentration- Cmax (PDR001)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of NIR178

Measure: Time of maximum concentration observed- Tmax (NIR178)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Plasma concentration time profiles of PDR001

Measure: Time of maximum concentration observed- Tmax (PDR001)

Time: Starting from the first dose of study treatment to Cycle 6 Day 1

Description: Proportion of patients with a best overall response of CR or PR or SD

Measure: Determine the disease control rate (DCR)

Time: Until study discontinuation (an average of 6 months)

Description: Proportion of patients with a best overall response of CR or PR or SD

Measure: Determine the duration of response (DoR)

Time: Every 12 weeks after the first 40 weeks until disease progression

Description: Time from start of treatment to date of the first documented progression or death in months

Measure: Progression free survival (PFS)

Time: Every 12 weeks after the first 40 weeks until disease progression

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

- Patients with EGFR positive NSCLC with a T790M mutation must have progressed on osimertinib or discontinued due to toxicity. --- T790M ---



HPO Nodes


HPO: