A study to continue providing GME751 (a new medicine that is similar to pembrolizumab) to participants who are eligible for pembrolizumab treatment after participation in previous studies (CGME751A12101 or CGME751A12301)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

H e x a l AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

30 Oct 2024 → ongoing

Decision date (initial)

2025-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Hexal AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs

Conditions and MedDRA coding

Melanoma and Non-small-cell lung cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Signed informed consent must be obtained prior to participation in the study.
2. Participant must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) on the day of signing informed consent.
3. Participants of Study 101 or Study 301 who are judged to benefit from continued treatment with pembrolizumab by their Investigator.
4. Participants who have demonstrated compliance with Study 101 or Study 301 protocol requirements as assessed by their Investigator.
5. Participants who completed Study 101 or Study 301 as per protocol OR who discontinued treatment and consequently study participation in Study 101 or 301 Note: Examples for discontinued participants: • Study 101, e.g. participants who did not receive pembrolizumab within the predefined visit schedule window, • Study 301, e.g. participants with unacceptable toxicity to background chemotherapy Cis-/Carboplatin and/or Pemetrexed.
6. Participants who discontinued from Study 301 based on Sponsor´s decision to terminate Study 301

Exclusion criteria 4

1. Participants who experienced disease recurrence during Study 101 or Study 301
2. Participants who experienced disease progression during Study 301
3. Participants who experienced unacceptable toxicity related to pembrolizumab during Study 101 or Study 301
4. Participants who have full reimbursable access to Keytruda for their indication.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cohort A (Melanoma): SAEs up to 6 – 12 months (EOS/ED) after start of treatment in Study 302 Cohort B (NSCLC): SAEs up to 12- 24 months (EOS/ED) after start of treatment in Study 302

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

H e x a l AG

Sponsor organisation

H e x a l AG

Address

Industriestrasse 25

City

Holzkirchen

Postcode

83607

Country

Germany

Scientific contact point

Organisation

H e x a l AG

Contact name

Biosimilar Clinical Trials Information Point

Public contact point

Organisation

H e x a l AG

Contact name

Biosimilar Clinical Trials Information Point

Third parties 1

Locations

3 EU/EEA countries · 27 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 18 files

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

Application history

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