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.

Study 302 is a rollover study of Studies 101 and
301 with the purpose of providing continued pembrolizumab treatment to
participants who are eligible and have proven continued benefit from
pembrolizumab before being enrolled in Study 302. The pembrolizumab dosing in
Study
302 should continue to follow the schedule used in Study 101 or 301. To allow
for a seamless
transition into Study 302, screening and enrollment for Study 302 should
match with the EOS or ED visit in Study 101 or 301 and the participant’s
pembrolizumab dosing schedule. If EOS or ED visit of Study 101 or 301 cannot
be aligned to match the participant´s pembrolizumab dosing schedule, a
separate visit for the first GME751 administration in Study 302 should be
scheduled to maintain the treatment cycle of 3 or 6 weeks (e.g. if the ED
visit for a participant of Study 101 is scheduled 28±7 days after last
treatment, the first pembrolizumab dosing in Study 302 should only be
performed 6 weeks after last treatment i.e., 1-3 weeks after the scheduled ED
visit).

Information and assessments that have been collected and performed for EOS/ED visit of Study 101 or 301 do not need to be repeated at C1D1 of Study 302. Results from the EOS or ED assessments (e.g. laboratory values, vital signs) in Study 101 or 301 can be re-used for eligibility assessment in Study 302. Enrollment in Study 302 requires a separate ICF. It must be signed before any assessment of Study 302 that is not covered by the ICF of Study 101 or 301 is performed.

All participants will receive GME751 study treatment regardless of prior exposure to Keytruda or GME751 in Study 101 or 301.