Avelumab Program Rollover Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck KGaA

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

21 Jun 2019 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514274-46-00

EudraCT number

2018-003711-21

ClinicalTrials.gov

NCT03815643

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 3

1. To evaluate the overall survival (OS) (for non-small cell lung cancer [NSCLC], renal cell carcinoma [RCC], urothelial carcinoma [UC] and ovarian cancer indications only)
2. To evaluate the progression free survival (PFS)
3. To evaluate duration of response (DR)

Conditions and MedDRA coding

Solid Tumors

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants are ≥ 18 years of age at the time of signing the informed consent.
2. Participants are under enrollment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA / Merck Serono Co., Ltd (Japan).
3. Participants currently enrolled in an avelumab parent study where the primary/main analysis has been completed and who are: • Currently on active avelumab treatment in any parent study, regardless of indication, OR • In long-term survival follow-up after treatment (participants in Non-Small Cell Lung Cancer [NSCLC], Renal Cell Carcinoma [RCC], Urothelial Carcinoma [UC], and ovarian cancer indications only), OR • Who experienced CR in the parent study and discontinued avelumab treatment according to the parent study protocol.
4. Participants are male or female. Participants on active treatment must agree to continue to use highly effective contraception (ie, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix 3 (Contraception) or as stipulated in national or local guidelines. Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 60 days after stopping study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately).
5. Participants can give signed informed consent, as indicated in Appendix 2 (Study Governance), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion criteria 5

1. Participants are pregnant or breastfeeding.
2. For participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients.
3. Participant has been enrolled in the comparator arm of avelumab parent study.
4. Participant has been withdrawn from avelumab parent study for any reason (Note: Participants in the Follow-up Period are eligible).
5. Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study.

Secondary endpoints 3

1. Overall Survival, from baseline in parent study to date of death due to any cause.
2. Progression Free Survival according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Investigator, from baseline in parent study until progressive disease (PD) or death due to any cause.
3. Duration Response assessed from complete response (CR) or partial response (PR) until PD or death due to any cause.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck KGaA

Sponsor organisation

Merck KGaA

Address

Frankfurter Strasse 250

City

Darmstadt

Postcode

64293

Country

Germany

Scientific contact point

Organisation

Merck KGaA

Contact name

Global Regulatory Affairs

Public contact point

Organisation

Merck KGaA

Contact name

Global Regulatory Affairs

Third parties 6

Locations

7 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 107 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications