Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

NCT03172936 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CMIW815X2102J2017-000707-25
• Study Type: interventional
• Target: 106
• Locations: 8 countries
• Sites: 12

Brief Summary

The purpose of this study was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.

Conditions

Solid Tumors and Lymphomas

Keywords

injected lesion; distal lesion; abscopal activity; intratumoral; checkpoint inhibitor; cyclic dinucleotide; programmed cell death

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLTs)

  A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with the combination of MIW815 (ADU-S100) and PDR001

  24 months

Secondary Outcomes (16)

• AUC inf

  36 months

• AUC last

  36 months

• AUC tau

  36 months

• Tmax

  36 months

• Cmax

  36 months

Study Arms (2)

Dosing Schedule A

EXPERIMENTAL

Patients were treated with MIW815 (ADU-S100) via intratumoral injection for 3 weeks followed by one week off in combination with a fixed intravenous dose of PDR001 given once per month

Drug: MIW815; Biological: PDR001

Dosing Schedule B

EXPERIMENTAL

Patients were treated with MIW815 (ADU-S100) via intratumoral injection given once a month in combination with a fixed intravenous dose of PDR001 given once per month

Drug: MIW815; Biological: PDR001

Interventions

MIW815 DRUG

MIW 815 (ADU-S100) is a STING agonist

Dosing Schedule A; Dosing Schedule B

PDR001 BIOLOGICAL

PDR001 is an anti-PD-1 antibody

Dosing Schedule A; Dosing Schedule B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions
• Must have two biopsy accessible lesions:

You may not qualify if:

• Symptomatic or untreated leptomeningeal disease. Presence of symptomatic central nervous system metastases Impaired cardiac function or clinically significant cardiac disease Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
• Active infection requiring systemic antibiotic therapy. Known history of human immunodeficiency virus infection. Active Epstein-Barr virus, hepatitis B virus or hepatitis C virus Malignant disease, other than that being treated in this study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60637, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98105, United States

Location

Novartis Investigative Site

North Sydney, New South Wales, 2060, Australia

Location

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 104 0045, Japan

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.

  PMID: 32823563 DERIVED

Related Links

• Study Results
• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Lymphoma

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nancy Lewis, MD

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was comprised of two treatment arms. Group A included patients with accessible solid tumors and lymphomas. This group received a fixed dose of PDR001 intravenous on day 1 of every 28 day cycle and intratumoral injections of MIW815 (ADU-S100) on days 1, 8 and 15 of every 28 day cycle. Group B included patients with accessible solid tumors and lymphomas. This group received a fixed dose of PDR001 intravenous on day 1 of every 28 day cycle and an intratumoral injection of MIW815 (ADU-S100) on day 1 of every 28 day cycle. Once the maximum tolerated dose and/or recommended dose for expansion had been determined, the plan was to open the expansion part of the study. However, the dose expansion phase of the study was not opened to enrollment due to the program's early termination.

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: September 8, 2017
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); CA (1); NL (1); AU (2); CH (1); DE (1); JP (1); US (4)