CompletedPhase 1

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

United States, Belgium, Canada283 participantsStarted 2016-08-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with advanced/metastatic cancer, with measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant to standard therapy, and for whom no effective therapy is available. Patients must fit into one of the following groups: * Colorectal cancer (CRC) (not mismatch repair deficient by local assay including PCR and/or immunohistochemistry) * Non-small cell lung cancer (NSCLC) (adenocarcinoma) * Triple Negative Breast Cancer (TNBC) (D * ECOG Performance Status ≤ 2 * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at baseline, and again during therapy on this study. * Prior therapy with PD-1/PDL-1 inhibitors is allowed provided any toxicity attributed to prior PD-1- or PD-L1-directed therapy did not lead to discontinuation of therapy. * Written informed consent must be obtained prior to any screening procedures other than procedures performed as part of standard of care. Exclusion Criteria: * Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy, or increasing doses of corticosteroids within the prior 2 weeks. * History of severe hypersensitivity reactions to other monoclonal antibodies. * Out of range laboratory values for measures of hepatic and renal function, electrolytes a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety

Timeframe: Throughout the study at every visit, an average of 1 year

Changes between baseline and post-baseline laboratory parameters and vital signs.

Timeframe: Baseline and throughout the study at every visit, an average of 1 year

Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only)

Timeframe: During the first two cycles; Cycle = 28 days

Frequency of dose interruptions

Timeframe: Throughout the study at every visit, an average of 1 year

Dose intensities

Timeframe: 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

Timeframe: Throughout the study at every visit, an average of 1 year

Trial details

NCT IDNCT02900664

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-17

View on ClinicalTrials.gov More Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Frequency of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety

Timeframe: Throughout the study at every visit, an average of 1 year

Changes between baseline and post-baseline laboratory parameters and vital signs.

Timeframe: Baseline and throughout the study at every visit, an average of 1 year

Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only)

Timeframe: During the first two cycles; Cycle = 28 days

Frequency of dose interruptions

Timeframe: Throughout the study at every visit, an average of 1 year

Dose intensities

Timeframe: 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

Timeframe: Throughout the study at every visit, an average of 1 year