Continuation of capmatinib treatment for patients with advanced solid tumors

An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.

This study is for patients with advanced solid tumors who have already tried capmatinib and want to keep using it to see if it continues to help them safely.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: capmatinib
• Locations: 17 sites (Boston, Massachusetts and 16 other locations)
• Trial ID: NCT03040973 on ClinicalTrials.gov

What this trial studies

This study allows patients who have previously participated in a Novartis-sponsored trial to continue receiving capmatinib treatment, either as a standalone therapy or in combination with other treatments. It is an open-label, multi-center rollover study focused on assessing the long-term safety of capmatinib in eligible participants who are deemed to benefit from ongoing treatment. Participants will begin treatment immediately after providing informed consent, with regular follow-ups for safety assessments. The study accommodates alternative care methods during public health emergencies to ensure continued patient support.

Who should consider this trial

Good fit: Ideal candidates are patients currently receiving capmatinib treatment in a prior Novartis-sponsored study who are benefiting from it.

Not a fit: Patients who are not currently receiving capmatinib or who have not shown clinical benefit from the treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide ongoing access to effective treatment for patients with advanced solid tumors that are dependent on cMET.

How similar studies have performed: Other studies involving capmatinib and similar treatments have shown promise, indicating a potential for success in this approach.

Eligibility criteria

Inclusion criteria:

1. Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition participants to rollover study) as single agent or in combination or is receiving a combination treatment alone. This includes all participants treated with capmatinib in combination with other treatment that permanently discontinued capmatinib for any reason but are still receiving the combination treatment as single agent. In order to receive the combination treatment as single agent in the rollover study, the treatment needs to be not accessible to the participant outside a clinical trial (e.g. commercially not available or reimbursed).
2. Participant is currently deriving clinical benefit from study treatment as determined by the Investigator
3. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
4. Written informed consent obtained prior to enrolling in the rollover study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion criteria:

1. Participant is currently not receiving any study treatment due to unresolved toxicities for which study treatment dosing has been interrupted or permanently discontinued in the parent protocol (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study treatment dosing to resume)
2. Pregnant or nursing (lactating) women
3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for at least 7 days or following combination treatment parent trial recommendation (whichever is longer) of study treatment after stopping medication. Highly effective contraception methods include:
4. Concurrent participation in another clinical study other than a parent clinical study
5. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and COVID-19 vaccines) within 30 days prior to the first dose of study treatment

Where this trial is running

Boston, Massachusetts and 16 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Novartis Investigative Site — Leuven, Belgium (Active_not_recruiting)
• Novartis Investigative Site — Edmonton, Alberta, Canada (Completed)
• Novartis Investigative Site — Shanghai, Shanghai, China (Recruiting)
• Novartis Investigative Site — Kunming, Yunnan, China (Recruiting)
• Novartis Investigative Site — Copenhagen, Denmark (Completed)
• Novartis Investigative Site — Dijon, Cote D Or, France (Completed)
• Novartis Investigative Site — Dresden, Germany (Withdrawn)
• Novartis Investigative Site — Hannover, Germany (Active_not_recruiting)
• Novartis Investigative Site — Koeln, Germany (Active_not_recruiting)
• Novartis Investigative Site — Milano, Mi, Italy (Active_not_recruiting)
• Novartis Investigative Site — Perugia, Pg, Italy (Completed)
• Novartis Investigative Site — Seoul, Korea, Republic of (Completed)
• Novartis Investigative Site — Seoul, Korea, Republic of (Completed)
• Novartis Investigative Site — Seoul, Korea, Republic of (Withdrawn)
• Novartis Investigative Site — Singapore, Singapore (Active_not_recruiting)
• Novartis Investigative Site — Madrid, Spain (Completed)

Study contacts

• Principal investigator: Toni Wozniak, MD — Barbara Ann Karmanos Cancer Institute
• Study coordinator: Novartis Pharmaceuticals

Conditions Advanced Solid Tumors Which Are cMET-dependent; capmatinib; INC280; Nazartinib; Gefitinib; Osimertinib; EGF816; NSCLC