Active — Not RecruitingPhase 3

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

Argentina, Bulgaria, Chile163 participantsStarted 2024-09-12

Plain-language summary

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Chemotherapy must have begun within 12 weeks after the resection surgery.
✓. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose

Timeframe: 21 days

AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)

Timeframe: Weeks 16-19

NCT IDNCT06430866

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-14