Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON51870
NL-OMON51870
Recruiting
Phase 3

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer - MK3475-B49

Merck Sharp & Dohme (MSD)0 sites24 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsBreast cancerBreast carcinoma10006291

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast cancer
Sponsor
Merck Sharp & Dohme (MSD)
Enrollment
24
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Merck Sharp & Dohme (MSD)

Eligibility Criteria

Inclusion Criteria

  • •The main inclusion criteria are listed here. For a complete list of inclusion
  • •please refer to the research protocol.
  • •1\. Has locally recurrent inoperable or metastatic HR\+/HER2\- breast cancer,
  • •which has not been previously treated with cytotoxic chemotherapy in the
  • •noncurative setting.
  • •2\. Has progressed on prior endocrine therapy and is now a chemotherapy
  • •candidate, meeting the characteristics in regard to previous treatments of one
  • •of the 4 groups.
  • •3\. Has presented a documented radiographic disease progression
  • •4\. Is a chemotherapy candidate that meets the criteria as described in the

Exclusion Criteria

  • •The main exclusion criteria are listed here. For a complete list of exclusion
  • •please refer to the research protocol.
  • •1\. Has breast cancer amenable to treatment with curative intent.
  • •2\. Has a history or current evidence of any condition, therapy, or laboratory
  • •abnormality as defined in the protocol.
  • •3\. Has significant cardiac disease as defined in the protocol
  • •4\. Has advanced/metastatic, symptomatic visceral spread at risk of rapidly
  • •evolving into life\-threatening complications, see more information in the study
  • •5\. Has skin only disease. Participants who have metastatic disease fulfilling
  • •the previous criteria in addition to skin disease can be enrolled.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentAlcoholic hepatitisMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2020-004534-38-DEDURECT Corporation300
Active, not recruiting
Phase 1
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentAlcoholic hepatitisMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2020-004534-38-FRDURECT Corporation300
Active, not recruiting
Not Applicable
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
EUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
Active, not recruiting
Phase 1
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
EUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282
Active, not recruiting
Phase 1
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT ChemotherapyFollowed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)Histologically documented gastric or gastroesophageal junction adenocarcinoma withresectable disease (Stage II or higher per AJCC 8th edition).MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2019-001555-40-DKAstraZeneca AB900