Clinical trial · Interventional
Avelumab Program Rollover Study
An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
NCT03815643CI-TRIAL-00116115active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avelumab
- interventionNames
- Drug: Avelumab
Primary outcomes (1)
- measure
- Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events
- timeFrame
- From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab)
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- From baseline up to 5 years
- measure
- Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research \& Development Institute, Inc. / Merck KGaA, Darmstadt, Germany * Merck Serono Co., Ltd (Japan) * Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment * Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists * Other protocol defined inclusion criteria could apply. Exclusion Criteria: * Participants who are pregnant or breastfeeding * Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients * Participant has been enrolled in the comparator arm of avelumab parent study * Participant has been withdrawn from avelumab parent study for any reason * Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study * Other protocol defined exclusion criteria could apply.
References
Publications (0)
Data not yet available
No reference posted for this study.