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Antimetabolites

Pembrolizumab + Chemotherapy for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment

Must not have

Has received prior therapy with certain immunotherapy agents

Has a known germline BRCA mutation and has not received previous treatment with PARP inhibition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 76 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess if pembrolizumab, when combined with chemotherapy, is more effective in treating hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer than chemotherapy alone. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

Who is the study for?

This trial is for adults with HR+/HER2- breast cancer that's locally recurrent and inoperable or has spread (metastatic), who haven't had chemotherapy for this condition before, but have progressed after endocrine therapy. They should be candidates for chemotherapy, have a certain level of PD-L1 protein on their tumor cells, good organ function, measurable disease per RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.

What is being tested?

The study tests if pembrolizumab combined with the investigator's choice of chemotherapy improves survival without cancer progression compared to placebo plus chemotherapy in patients whose tumors express PD-L1. The effectiveness will be measured by how long patients live without their disease getting worse (PFS) and overall survival (OS).

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug entering the body, fatigue, skin issues like rash or itching, digestive problems like diarrhea or nausea, liver function changes and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is HR+/HER2-, not treated with chemotherapy for advanced stages.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has worsened after hormone therapy, and I am now eligible for chemotherapy.

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My cancer has worsened despite the last hormone therapy I received.

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I have provided a recent biopsy from a cancer area not treated with radiation.

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My breast cancer is HR+ and HER2- with a PD-L1 CPS of 1 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with immunotherapy before.

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I have a BRCA mutation and haven't been treated with PARP inhibitors.

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I have an active case of tuberculosis.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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I have received an organ or tissue transplant from another person.

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I am currently being treated for an infection.

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My cancer is only in my skin.

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I have had chemotherapy for breast cancer that has returned or spread and cannot be removed by surgery.

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I am severely allergic to pembrolizumab or its ingredients, or to the chemotherapy I plan to receive.

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I have active cancer spread to my brain or spinal cord.

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My breast cancer can be treated with the goal of curing it.

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I haven't had radiotherapy or needed steroids for side effects in the last 2 weeks.

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I have a serious heart condition.

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My cancer has spread to other organs and is causing symptoms.

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I haven't had cancer treatment with experimental drugs in the last 4 weeks.

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I have or had lung inflammation that needed steroids.

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I have been treated for an autoimmune disease in the last 2 years.

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I have been diagnosed with cancer in the lining of my brain and spinal cord.

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I have been diagnosed with HIV.

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I have tested positive for COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 76 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 76 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 76 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

Secondary study objectives

Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

+30 more

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + ChemotherapyExperimental Treatment5 Interventions

Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.

Group II: Placebo + ChemotherapyActive Control6 Interventions

Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 PO BID on Days 1-14 Q3W for up to 35 administrations.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5890

paclitaxel

1996

Completed Phase 3

~4310