Trials / Completed
CompletedNCT02611960
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
A Two-arm, Open-label, Randomized Phase III Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 233 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study of pembrolizumab (MK-3475) versus standard treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. With Amendment 7 (effective 2-March-2022), upon study completion, participants will be discontinued and may be enrolled in an extension study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Capecitabine | oral tablet |
| DRUG | Gemcitabine | IV infusion |
| DRUG | Docetaxel | IV infusion |
Timeline
- Start date
- 2016-04-18
- Primary completion
- 2020-11-30
- Completion
- 2022-09-30
- First posted
- 2015-11-23
- Last updated
- 2023-07-13
- Results posted
- 2021-12-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02611960. Inclusion in this directory is not an endorsement.