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Pembrolizumab placebo (saline)
This is a saline placebo control with no active pharmacological mechanism.
This is a saline placebo control with no active pharmacological mechanism. Used for Control arm in pembrolizumab phase 3 clinical trials.
At a glance
| Generic name | Pembrolizumab placebo (saline) |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Saline placebo is an inert control substance used in clinical trials to establish baseline efficacy and safety of the active drug (pembrolizumab, a PD-1 inhibitor) through comparison. It contains no active pharmaceutical ingredient and serves only as a comparator arm in phase 3 trials.
Approved indications
- Control arm in pembrolizumab phase 3 clinical trials
Common side effects
- Injection site reactions
- Adverse events attributable to underlying disease progression
Key clinical trials
- EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (PHASE3)
- A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) (PHASE3)
- Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) (PHASE3)
- Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension (PHASE3)
- Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pembrolizumab placebo (saline) CI brief — competitive landscape report
- Pembrolizumab placebo (saline) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI