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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 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

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:
Anaplastic thyroid carcinoma
Neoplasm of the thyroid gland
Genes 91
ECE1 CASP10 NRTN PTEN JAG1 AKT1 SDHC PTEN MLH1 HABP2 PMS2 APC CDC73 EDN3 LMNA FLCN CDKN1B SEMA3C CDC73 TG GREM1 SLC26A4 DICER1 MSH3 MSH6 RET GNAS APC HABP2 PIK3CA RASGRP1 KCNJ10 EPCAM RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN TGFBR2 SEMA4A PIK3CA FAN1 MINPP1 FAS RET MINPP1 APC MSH3 BMPR1A FAS KRAS CDKN2B KEAP1 DICER1 MSH2 FOXI1 BMPR1A EDNRB PRKAR1A NRAS MLH3 SEC23B WRN PTEN HRAS PTEN SLC26A4 CDKN2C RET PIK3CA NKX2-1 FOXE1 SDHB KCNJ10 FASLG MEN1 CDKN1A RPS20 CDC73 SEMA3D PRKAR1A FOXE1 CDKN1B GDNF PMS1 APC AKT1 APC FOXI1
Thyroid adenoma
Genes 19
CDKN1B FAS CASP10 CDC73 MSH3 FAS FASLG CDKN2B MEN1 CDKN1A AKT1 MSH3 PIK3CA RASGRP1 PRKAR1A PTEN CDKN1B PRKCD CDKN2C
Thyroid carcinoma
Genes 53
CASP10 JAG1 SDHC HABP2 APC CDC73 FLCN TG GREM1 SLC26A4 DICER1 APC HABP2 RASGRP1 KCNJ10 RET KLLN SRGAP1 SDHD PRKCD SEC23B PTEN PIK3CA MINPP1 FAS RET MINPP1 APC FAS KEAP1 DICER1 FOXI1 BMPR1A PRKAR1A NRAS SEC23B WRN PTEN HRAS SLC26A4 RET NKX2-1 FOXE1 SDHB KCNJ10 FASLG CDC73 PRKAR1A FOXE1 APC AKT1 APC FOXI1
Thyroid follicular adenoma