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Report for Clinical Trial NCT02404441

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies

The purpose of this "first-in-human" study of PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells. This study has been designed as a phase I/II, multi-center, open-label study starting with a phase I dose escalation part followed by a phase II part. PDR001 will be administered every 2 weeks until patient experiences unacceptable toxicity, progressive disease per immune related Response Criteria (irRC) and/or treatment is discontinued at the discretion of the investigator or the patient.

NCT02404441 Me Melanoma NSCLC Triple Negative Breast Cancer Anaplastic Thyroid Cancer Other Solid Tumors
MeSH:Thyroid Neoplasms Triple Negative Breast Neoplasms Thyroid Carcinoma, Anaplastic
HPO:Anaplastic thyroid carcinoma Neoplasm of the thyroid gland Thyroid adenoma Thyroid carcinoma Thyroid follicular adenoma

1 Interventions

Name: PDR001

Description: anti-PD1 antibody
Type: Biological
Group Labels: 2

Selected tumor types patients with solid tumors


Primary Outcomes

Description: To estimate the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001

Measure: Part l: The exposure (AUC(0-336h)) after first dose of treatment

Time: 8 months

Description: To estimate the RP2D and/or the MTD for PDR001

Measure: Part l: Incidence of dose limiting toxicities (DLTs)

Time: 8 months

Description: As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - to estimte the anti-tumor activity of PDR001. Each cycle = 28 days

Measure: Part ll: Overall response Rate (ORR)

Time: 61 months

Secondary Outcomes

Description: To assess emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment = expected to be in average 1 year after the start of study treatment

Measure: Presence and/or concentration of anti-PDR001

Time: 42 months

Description: Preliminary antitumor activity of PDR001

Measure: Overall Response Rate (ORR) - Phase l only

Time: 27 months

Description: Preliminary antitumor activity of PDR001

Measure: Progression Free Survival (PFS) - Phase l/ll

Time: 61 months

Description: Preliminary antitumor activity of PDR001

Measure: Duration of Response (DOR) - Phase l/ll

Time: 61 months

Description: Preliminary antitumor activity of PDR001

Measure: Disease Control Rate (DCR) - Phase l/ll

Time: 61 months

Description: Preliminary antitumor activity of PDR001

Measure: Overall Response Rate (ORR) per immune related Response Criteria - Phase ll only

Time: 61 months

Description: Characterize the pharmacokinetic (PK) profile of PDR001

Measure: Serum pharmacokinetic (PK) parameter AUCs

Time: 37 months

Description: Characterize the pharmacokinetic (PK) profile of PDR001

Measure: Serum Pharmacokinetic (PK) parameter Cmax

Time: 37 months

Description: Characterize the pharmacokinetic (PK) profile of PDR001

Measure: Serum Pharmacokinetic (PK) parameter Tmax

Time: 37 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 L858R

Only patients with EGFR mutation-negative tumor are eligible (defined as negative for exon 19 deletions and for the L858R mutation in EGFR at a minimum; however, if more extensive EGFR mutation testing has been performed, the tumor must not harbor any known activating EGFR mutations in Exons 18-21 in order to be considered EGFR mutation-negative). --- L858R ---



HPO Nodes


HPO: