Advanced Solid TumorsPhase 1NCT04058756
Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
A Phase 1 study testing PDR001 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 48 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PDR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 48 sitesin 17 countries
- Study dates
- 30 Oct 2019to 30 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
48 sites in 17 countries.
48 sites in 17 countries
Italy8 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Siena, SI, 53100
Spain6 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Valencia, 46010
France5 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Villejuif, 94800
Germany4 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Ulm, 89081
United States3 sites
MD Anderson Cancer Center Uni of Te
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
Providence Portland Medical Center
Portland, Oregon, 97123
Hong Kong3 sites
Novartis Investigative Site
High West, 999077
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Novartis Investigative Site
Hong Kong, 999077
Thailand3 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Chiang Mai, 50200
Novartis Investigative Site
Songkhla, Hat Yai, 90110
Belgium2 sites
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Canada2 sites
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
China2 sites
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Guangzhou, 510060
Hungary2 sites
Novartis Investigative Site
Budapest, H 1122
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Poland2 sites
Novartis Investigative Site
Gdansk, 80-214
Novartis Investigative Site
Poznan, 60-693
South Korea2 sites
Novartis Investigative Site
Seoul, Seoul, 03080
Novartis Investigative Site
Seoul, 05505
Netherlands1 site
Novartis Investigative Site
Leiden, South Holland, 2333 ZA
About this study
Official title: An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments
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
- Being tested
- PDR001
- Keywords
- Phase Ib, PDR001, PD-1, continued access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDR001Drug
PDR001
| Study group | Role | What they receive |
|---|---|---|
| PDR001 | Experimental | All subjects in all combination will be entered in one arm Receives: Drug: PDR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and nature of AE and SAE by subject
Safety data.
Measured: 5 years
Number of subjects with PDR001 dose interruption and/or reduction
Measured: 5 years
Secondary outcomes (2)
Number of subjects receiving PDR001
Measured: 5 years
Subject's exposure duration
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start30 Oct 2019
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058756
- Sponsor's protocol ID
- CPDR001X2X01B
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2019
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments
- ClinicalTrials.gov ID
- NCT04058756
- Acronym / sponsor ID
- CPDR001X2X01B
- Conditions
- Advanced Solid Tumors
- Keywords
- Phase Ib, PDR001, PD-1, continued access
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDR001 | Experimental | Drug: PDR001All subjects in all combination will be entered in one arm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDR001PDR001 | Drug | PDR001 |
Primary outcome
Frequency and nature of AE and SAE by subject
Time frame: 5 years
Safety data.
Number of subjects with PDR001 dose interruption and/or reduction
Time frame: 5 years
2 secondary outcomes
Number of subjects receiving PDR001
Time frame: 5 years
Subject's exposure duration
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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RecruitingPhase 2
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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
48 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDR001 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 48 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Italy, Spain, France, Germany, United States and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and nature of AE and SAE by subject (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.