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An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies (Jimmy Extension)

A rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies (Jimmy Extension)

Stehle Michael

Hexal AG

Industriestr. 25, 83607, Holzkirchen, Germany

sandoz.disclosure@sandoz.com

Rosario Chikako

Parexel International Inc.

Kayabacho Tower, 1-21-2, Shinkawa, Chuo-ku, Tokyo

+81-80-8929-3137

Clinicaltrial-registration@parexel.com

Pending

Jan. 12, 2025

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

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.
Other protocol-defined inclusion criteria apply.

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 reimbursable access to Keytruda for their indication.
5. Participants who interrupted pembrolizumab in Study 301 and cannot resume pembrolizumab treatment at the assessment of eligibility for Study 302.
6. Use of other investigational drugs after completion or discontinuation of Study 101 or 301.
7. Requirement of any other form of antineoplastic therapy except GME751 and pemetrexed while on study.
8. Surgery with inadequate external/internal wound healing within 3 weeks prior to first administration of study treatment.
9. Previously reported hypersensitivity reaction to any recombinant protein drugs or pemetrexed or any of the excipients used in GME751 and pemetrexed.
10. History or current diagnosis of cardiac disease that may increase the risk associated with study participation as per Investigators assessment.
11. Presence of clinically significant active infections necessitating systemic therapy (as per the Investigators discretion) that may increase the risk associated with study participation.
12. Received live vaccine =<30 days before the first study treatment.
13. Symptomatic ascites or pleural effusion if they represent clinical signs of progression or unacceptable toxicity. If progression and unacceptable toxicity can be excluded, a participant who is clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
14. Current uncontrolled and untreated status of hypothyroidism or hyperthyroidism based on the Investigators clinical judgment.
15. Pregnant (confirmed by urine or serum pregnancy test) or breastfeeding women.
16. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective methods of contraception while taking study treatment and for a minimum of 120 days after stopping study treatment.
17. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for a minimum of 120 days after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
Other protocol-defined exclusion criteria apply.

Both

Untreated metastatic non-squamous non-small cell lung cancer (NSCLC)

The GME751 will be administered at a dose of 200 mg with or without background chemotherapy via i.v. infusion every 3 weeks until disease progression/recurrence, unacceptable toxicity related to pembrolizumab, or for up to 24 months maximum treatment duration of pembrolizumab (including treatment during Study CGME751A12301), whichever occurs first.

Participants who were previously enrolled in Study 301 will enter Cohort B (NSCLC). Participants will receive GME751 study treatment regardless of prior exposure to Keytruda or GME751 in Study 301.

Cohort B (NSCLC): The occurrence of SAEs up to 12 - 24 months (EOS/ED) after start of treatment in Study 302

No secondary endpoints are defined for this study.

+81-29-240-7711

Jan. 27, 2025

No

Bosnia and Herzegovina/Brazil/Georgia/India/Lithuania/Malaysia/Mexico/Moldova/Philippines/Romania/Serbia/South Africa/South Korea/Thailand/Turkey/Taiwan/United States/Viet Nam/North Macedonia