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History of Changes for Study: NCT03815643
Avelumab Program Rollover Study
Latest version (submitted June 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 22, 2019 None (earliest Version on record)
2 February 27, 2019 Study Status and IPDSharing
3 March 21, 2019 Study Status
4 May 8, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 June 24, 2019 Study Status
6 July 24, 2019 Study Status and Contacts/Locations
7 August 20, 2019 Study Status
8 September 12, 2019 Study Status
9 October 15, 2019 Study Status and Contacts/Locations
10 November 18, 2019 Study Status, IPDSharing, Contacts/Locations and Study Identification
11 December 9, 2019 Study Status
12 January 17, 2020 Study Status
13 April 10, 2020 Study Status
14 May 21, 2020 Study Status
15 June 24, 2020 Study Status, References, Contacts/Locations and Study Design
16 July 24, 2020 Study Status and Study Design
17 August 14, 2020 Study Status and Study Design
18 September 21, 2020 Study Status
19 October 21, 2020 Study Status
20 November 20, 2020 Study Status and Study Design
21 December 15, 2020 Study Status
22 January 19, 2021 Study Status
23 February 9, 2021 Study Status
24 March 10, 2021 Study Status
25 April 7, 2021 Study Status
26 May 5, 2021 Study Status
27 June 17, 2021 Recruitment Status, Contacts/Locations and Study Status
28 September 20, 2021 Study Status
29 December 15, 2021 IPDSharing, Study Status and Study Design
30 March 22, 2022 Study Status
31 June 15, 2022 Study Status
Comparison Format:

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Study NCT03815643
Submitted Date:  January 22, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: MS100070_0176
Brief Title: Avelumab Program Rollover Study
Official Title: An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Not yet recruiting
Study Start: January 31, 2019
Primary Completion: January 28, 2024 [Anticipated]
Study Completion: January 28, 2024 [Anticipated]
First Submitted: January 22, 2019
First Submitted that
Met QC Criteria:
January 22, 2019
First Posted: January 24, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 22, 2019
Last Update Posted: January 24, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: EMD Serono Research & Development Institute, Inc.
Responsible Party: Sponsor
Collaborators: Merck KGaA, Darmstadt, Germany
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumors
Keywords: Avelumab
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma (RCC)
Urothelial carcinoma (UC)
Ovarian cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 264 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Avelumab Drug: Avelumab
Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).
Other Names:
  • MSB0010718C
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
[ Time Frame: From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab) ]

Secondary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: From baseline up to 5 years ]

2. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
[ Time Frame: From baseline up to 5 years ]

3. Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR)
[ Time Frame: From baseline up to 5 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Communication Center
Telephone: +49 6151 72 5200
Email: service@emdgroup.com
Central Contact Backup: US Medical Information
Telephone: 888-275-7376
Email: service@emdgroup.com
Study Officials: Medical Responsible
Study Director
Merck KGaA, Darmstadt, Germany
Locations: United States, Massachusetts
Please Contact U.S. Medical Information
Rockland, Massachusetts, United States, 02370
Germany
Please Contact the Communication Center
Darmstadt, Germany, 64293
Open or close this module IPDSharing
Plan to Share IPD: Yes
EMD Serono, Inc. is committed to sharing patient-level data and supporting documentation from applicable studies according to company policies. Further information on data sharing and how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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