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Cancer drug spartalizumab gets extended safety check in ongoing patients

NCT ID NCT04058756

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study follows patients with advanced solid tumors who are already benefiting from the cancer drug spartalizumab (PDR001). The goal is to continue monitoring safety and side effects while allowing patients to keep receiving the treatment. About 120 participants are enrolled from earlier Novartis studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spartalizumab (PDR001)
What this could lead to
If this trial succeeds, it could provide continued access to spartalizumab for patients who are already benefiting, while gathering long-term safety data.
What could go wrong
This is a small, early-phase rollover study, not designed to prove effectiveness. It only includes patients already doing well on the drug, so results may not apply to a broader population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

120 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Other protocol defined inclusion criteria may apply Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • MD Anderson Cancer Center Uni of Te

    Houston, Texas, 77030, United States

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Guangzhou, 510060, China

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Hong Kong, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    High West, 999077, Hong Kong

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, H 1122, Hungary

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    Aviano, PN, 33081, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Leiden, South Holland, 2333 ZA, Netherlands

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Poznan, 60-693, Poland

  • Novartis Investigative Site

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Providence Portland Medical Center

    Portland, Oregon, 97123, United States

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