NCT02900664|CompletedPhase 1FDA Drug

A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Novartis Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

CPDR001X21032016-000633-49

Study Type

interventional

Target

283

Locations

9 countries

Sites

Timeline

RegisteredSep 2016

StartedAug 2016

CompletionMar 2021

Brief Summary

The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

283

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Aug 2016

Longer than P75 for phase_1

Geographic Reach

9 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

May 17, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

August 23, 2016

Completed

22 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed

Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

4.6 years

First QC Date

May 17, 2016

Last Update Submit

March 15, 2022

Conditions

Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma

Keywords

CRCTNBCNSCLC (adenocarcinoma)ImmunomodulationBiomarkersBayesian logistic regression modelPDR001ImmunotherapyRectal cancerMetastatic adenocarcinomaColorectal cancercolon cancerbowel cancercancer of the colon and rectumColorectal adenocarcinomaadenocarcinomacoloncancerlarge intestinelarge intestine cancercolorectum cancerTriple-negative breast cancer (TNBC)TNBC, basal typesecretory celladenoid cysticmedullaryductal carcinomainflammatorybreast carcinomabreast cancerbreast lumpPagets diseaseHER2 positive metastatic breast cancerbreast cancer positive for human epidermal growth factor receptor 2 (HER2)breast cancer progressionestrogen-receptor (ER) positive(+) breast cancerNon-small cell lung carcinoma (NSCLC)treatment of lung cancer after first metastasislung cancerlung adenocarcinomaSquamous cell lung carcinomaLarge-cell lung carcinomaNon small cell lung carcinomaNon small cell lung cancerNon-small cell lung cancerNSCLCLarge cell lung carcinomaLarge cell lung cancerPagent's disease

Outcome Measures

Primary Outcomes (7)

Frequency of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
Throughout the study at every visit, an average of 1 year
Changes between baseline and post-baseline laboratory parameters and vital signs.
Baseline and throughout the study at every visit, an average of 1 year
Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only)
During the first two cycles; Cycle = 28 days
Frequency of dose interruptions
Throughout the study at every visit, an average of 1 year
Dose intensities
Throughout the study at every visit, an average of 1 year
Severity of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
Throughout the study at every visit, an average of 1 year
Frequency of dose reductions
Throughout the study at every visit, an average of 1 year

Secondary Outcomes (16)

Key secondary: Histopathology of tumor infiltrating lymphocytes (TILs)
Baseline and approximately after 2 cycles of treatment and at disease progression; Cycle = 28 days
Changes from baseline in electrocardiogram (ECG) parameters
Baseline and end of treatment, an average of 1 year
Best overall response (BOR)
T1: Every 2 cycles until the start of T2. T2: Every 2 cycles until cycle 3 and then every 3 cycles until PD; cycle = 28 days
Progression free survival (PFS) per irRC and RECIST v1.1
T1: Every 2 cycles until the start of T2. T2: Every 2 cycles until cycle 3 and then every 3 cycles until PD; cycle = 28 days
Treatment Free Survival (TFS)
T1: Every 2 cycles until the start of T2. T2: Every 2 cycles until cycle 3 and then every 3 cycles until PD; cycle = 28 days
+11 more secondary outcomes

Study Arms (23)

PDR + ACZ 100mg Q8W

EXPERIMENTAL

PDR + ACZ 100mg Q8W

Biological: PDR001Biological: ACZ885

PDR + ACZ 300mg Q8W

EXPERIMENTAL

PDR + ACZ 300mg Q8W

Biological: PDR001Biological: ACZ885

PDR + ACZ RDE TNBC

EXPERIMENTAL

PDR + ACZ Recommended Dose for Expansion (RDE) Triple Negative Breast Cancer (TNBC)

Biological: PDR001Biological: ACZ885

PDR + ACZ RDE NSCLC

EXPERIMENTAL

PDR + ACZ Recommended Dose for Expansion (RDE) Non-Small Cell Lung Cancer (NSCLC)

Biological: PDR001Biological: ACZ885

PDR + ACZ RDE CRC

EXPERIMENTAL

PDR + ACZ Recommended Dose for Expansion (RDE) Colorectal Cancer (CRC)

Biological: PDR001Biological: ACZ885