Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: GME751: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks , i.v. infusion Drug: Pemetrexed 500mg in 20 ml concentrate. Dose is 500 mg
Sponsors
Hexal AG
Parexel International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age 2. Signed informed consent must be obtained prior to participation in the study 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 6. Participants who discontinued from Study 301 based on Sponsor?s decision to terminate Study 301
Exclusion criteria
Exclusion criteria: 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. Use of other investigational drugs after completion or discontinuation of Study 101 or 301. 5. Previously reported hypersensitivity reaction to any recombinant protein drugs or pemetrexed or any of the excipients used in GME751 and pemetrexed. 6. Received live vaccine less than or equal to 30 days before the first study treatment. 7. Pregnant (confirmed by urine or serum pregnancy test) or breastfeeding women. 8. Participants who withdrew consent of participation during 101 and 301.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEsTimepoint: Cohort A (Melanoma): SAEs up to 6 to 12 months (End Of Study / Early Discontinuation) after start of treatment in Study 302 Cohort B (NSCLC): SAEs up to 12 to 24 months (End Of Study / Early Discontinuation) after start of treatment in Study 302 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
Bosnia and Herzegovina, Brazil, Georgia, India, Japan, Lithuania, Macedonia, Malaysia, Mexico, Philippines, Republic of Korea, Republic of Moldova, Romania, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, United States of America, Viet Nam
Contacts
Public ContactDr Annappa Kamath
Parexel International Clinical Research Private Limited
Outcome results
None listed