Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments

NCT04058756 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CPDR001X2X01B
• Study Type: interventional
• Target: 120
• Locations: 17 countries
• Sites: 48

Brief Summary

The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

Conditions

Advanced Solid Tumors

Keywords

Phase Ib; PDR001; PD-1; continued access

Outcome Measures

Primary Outcomes (2)

• Frequency and nature of AE and SAE by subject

  Safety data.

  5 years

• Number of subjects with PDR001 dose interruption and/or reduction

  5 years

Secondary Outcomes (2)

• Number of subjects receiving PDR001

  5 years

• Subject's exposure duration

  5 years

Study Arms (1)

PDR001

EXPERIMENTAL

All subjects in all combination will be entered in one arm

Drug: PDR001

Interventions

PDR001 DRUG

PDR001

PDR001

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is currently enrolled in a pre-defined Novartis-sponsored study and is receiving spartalizumab as single agent or in combination with other study treatment,
• Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.

You may not qualify if:

• Subject has been permanently discontinued from spartalizumab in the parent protocol for any reason other than enrollment in the Roll over Study
• Subject does not meet the criteria specified in the parent protocol criteria for continued study treatment.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (48)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97123, United States

Location

MD Anderson Cancer Center Uni of Te

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510515, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Novartis Investigative Site

Brno, 656 53, Czechia

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Marseille, 13273, France

Location

Novartis Investigative Site

Marseille, 13885, France

Location

Novartis Investigative Site

Villejuif, 94800, France

Location

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

High West, Hong Kong

Location

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

Location

Novartis Investigative Site

Pokfulam, 999077, Hong Kong

Location

Novartis Investigative Site

Budapest, H 1122, Hungary

Location

Novartis Investigative Site

Debrecen, 4032, Hungary

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Rozzano, MI, 20089, Italy

Location

Novartis Investigative Site

Modena, MO, 41124, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Leiden, South Holland, 2333 ZA, Netherlands

Location

Novartis Investigative Site

Gdansk, 80-952, Poland

Location

Novartis Investigative Site

Poznan, 60-693, Poland

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Valencia, 46010, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Interventions

spartalizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 16, 2019
• Study Start: October 30, 2019
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

HK (3); NL (1); BE (2); PL (2); FR (5); DE (4); CH (1); CZ (1); HU (2); US (3); TW (1); IT (8); TH (3); CN (2); CA (2); KR (2); ES (6)