Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2020-03-02

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and identify the recommended doses of single agent CJM112, and of CJM112 or LCL161 in combination with PDR001, in patients with relapsed and/or refractory multiple myeloma.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study is comprised of 3 treatment arms:

* Single agent CJM112 (Arm A)
* A fixed dose of PDR001 in combination with CJM112 (Arm B)
* A fixed dose of PDR001 in combination with LCL161 (Arm C)

Patients may switch from treatment on Arm A to the corresponding CJM112 dose level on Arm B at the time of disease progression if that dose level has been declared safe, and if patients do not have any DLTs on single agent CJM112. Otherwise, patients will switch to a lower dose level that has been declared safe. No other cross-over between treatment arms is allowed.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Dose escalation of single agent CJM112

Group Type EXPERIMENTAL

CJM112

Intervention Type DRUG

Anti-IL-17A antibody

Arm B

Dose escalation of CJM112 in combination with a fixed dose of PDR001

Group Type EXPERIMENTAL

PDR001

Intervention Type DRUG

Anti-PD1 antibody

CJM112

Intervention Type DRUG

Anti-IL-17A antibody

Arm C

Dose escalation of LCL161 in combination with a fixed dose of PDR001

Group Type EXPERIMENTAL

PDR001

Intervention Type DRUG

Anti-PD1 antibody

LCL161

Intervention Type DRUG

Oral small molecule SMAC-mimetic

Interventions

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PDR001

Anti-PD1 antibody

Intervention Type DRUG

CJM112

Anti-IL-17A antibody

Intervention Type DRUG

LCL161

Oral small molecule SMAC-mimetic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be able to provide written informed consent before any screening procedures.
* Male or female patients ≥18 years of age.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Must have measurable disease defined by at least 1 of the following 3 measurements:
* Serum M-protein ≥ 0.5 g/dL OR
* Urine M-protein ≥ 200 mg/24 hours OR
* Serum free light chain (FLC) \> 100 mg/L of involved FLC
* All patients must be willing to undergo a mandatory serial bone marrow aspirate and/or biopsy at screening and subsequently following treatment for the assessment of biomarker/pharmacodynamics and disease status. Exceptions may be considered after documented discussion with Novartis.

Exclusion Criteria

* Use of systemic chronic steroid therapy (≥10mg /day of prednisone or equivalent), or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal, or ophthalmic steroids are allowed.
* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
* Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur.
* Patients with prior known toxicity attributed to PD-1 or PDL-1 directed therapy, which led to discontinuation of these agents, will be excluded from the PDR001 containing arms of the study.
* Patients with prior known toxicity from IL-17A directed therapy, which led to discontinuation of the study treatment, will be excluded from CJM112 containing arms of the study.
* Any of the following clinical laboratory results during screening (i.e., within 28 days before the first dose of study treatment):

* Absolute neutrophil count (ANC) \< 1,000/mm3 without growth factor support within 7 days prior to testing
* Platelet count \< 75,000 mm3 without transfusion support within 7 days prior to testing
* Bilirubin \> 1.5 times the upper limit of the normal range (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the ULN

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No