What side effects are associated with this type of intervention?

Pembrolizumab, a PD-1 inhibitor used in ovarian cancer treatment, commonly causes side effects such as fatigue, rash, and diarrhea. Severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies (like hypothyroidism or hyperthyroidism), and nephritis. Immune modulation therapies, which enhance the immune response, can lead to similar immune-related adverse effects, potentially causing the immune system to attack normal tissues.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for use in various cancers, including ovarian cancer, particularly in combination with chemotherapy. Other immune-modulating therapies, such as nivolumab (another PD-1 inhibitor), have also been explored in ovarian cancer treatment. While specific FDA approvals for combinations like MK-4830 (immune modulation) with pembrolizumab are still under investigation, the use of immune checkpoint inhibitors in ovarian cancer represents a significant advancement in treatment options.

What other types of research exist?

Promising alternatives to MK-4830 + Pembrolizumab for ovarian cancer patients include: 1) Nivolumab (PD-1 Inhibition) combined with Ipilimumab (CTLA-4 Inhibition), which has shown efficacy in various cancers including melanoma and renal cell carcinoma. 2) Atezolizumab (PD-L1 Inhibition) combined with chemotherapy, which has been effective in non-small cell lung cancer and may be applicable to ovarian cancer. 3) Sequential therapy with OX40 agonists followed by anti-PD1 therapy, which has shown potential in pre-clinical studies and early clinical trials.

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Pembrolizumab + Chemotherapy + MK-4830 for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.

Is a candidate for interval debulking surgery.

Must not have

Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.

Planned or has been administered intraperitoneal chemotherapy as first-line therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 40 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether adding MK-4830 to pembrolizumab and standard treatments helps patients with a severe type of ovarian cancer. The goal is to see if this combination reduces cancer cells in the blood more effectively than just using pembrolizumab with standard treatments. The medications work by boosting the immune system to fight cancer.

Who is the study for?

This trial is for individuals with advanced ovarian cancer who can undergo chemotherapy and surgery, have adequate organ function, and can provide a tumor biopsy. It's not for those who've had certain recent treatments or vaccines, active infections including HIV or hepatitis B/C, other cancers within 3 years, prior ovarian cancer treatment, uncontrolled blood pressure, severe allergies to study drugs or their ingredients.

What is being tested?

The trial tests if adding MK-4830 to pembrolizumab (an immunotherapy drug) plus standard chemo works better than just pembrolizumab with chemo in reducing tumor DNA in the blood after three cycles of treatment in patients with high-grade serous ovarian cancer.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, immune system-related inflammation affecting various organs (like lungs), fatigue from chemotherapy agents like paclitaxel and carboplatin as well as potential bleeding risks associated with Avastin.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.

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I am eligible for surgery to remove as much cancer as possible.

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I can provide a sample of my tumor for testing.

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I am eligible for carboplatin and paclitaxel chemotherapy before and after surgery.

Exclusion Criteria

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

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I have cancer that has spread to my brain or spinal cord.

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I am receiving or will receive chemotherapy directly into my abdomen as my first treatment.

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I have not had major surgery in the last 3 weeks or am fully recovered from any major surgery.

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I have had bleeding issues within the last 6 months.

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I have or had lung inflammation that needed steroids.

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

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I am currently experiencing a significant blockage in my intestines.

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My high blood pressure is not under control.

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I have a history of hepatitis B or active hepatitis C.

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

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My ovarian cancer is not high-grade serous.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have received treatment for ovarian cancer before.

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

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I have been treated with specific immune system targeting drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 40 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA)

Secondary study objectives

Change From Baseline in Neoadjuvant ctDNA

Chemotherapy Response Score (CRS)

Number of Participants Who Discontinued Study Treatment Due to an AE

+2 more

Side effects data

From 2024 Phase 2 trial • 160 Patients • NCT05446870

49%

Anaemia

44%

Alopecia

38%

Nausea

37%

Constipation

27%

Neutropenia

25%

Neuropathy peripheral

25%

Fatigue

24%

Abdominal pain

20%

Asthenia

19%

Diarrhoea

19%

Myalgia

19%

Rash

18%

Leukopenia

18%

Arthralgia

16%

Procedural pain

15%

Thrombocytopenia

14%

Vomiting

13%

Pyrexia

13%

Hypokalaemia

11%

Alanine aminotransferase increased

11%

Decreased appetite

10%

Aspartate aminotransferase increased

10%

Neutrophil count decreased

10%

Pruritus

Paraesthesia

Headache

Hypothyroidism

Urinary tract infection

Platelet count decreased

Hypomagnesaemia

Back pain

Gamma-glutamyltransferase increased

Weight decreased

Dysgeusia

Insomnia

Hyperthyroidism

Oedema peripheral

Lymphocyte count decreased

White blood cell count decreased

Hypoalbuminaemia

Pain in extremity

Peripheral sensory neuropathy

Dyspnoea

Rash maculo-papular

Dizziness

Neurotoxicity

Hyperglycaemia

Anxiety

Pleural effusion

Dyspepsia

Stomatitis

Drug hypersensitivity

COVID-19

Hypocalcaemia

Cough

Hypertension

Febrile neutropenia

Pneumothorax

Respiratory failure

Procedural nausea

Vision blurred

Faecaloma

Large intestinal obstruction

Abdominal infection

Peritoneal abscess

Peritonitis bacterial

Post procedural infection

Sialoadenitis

Wound dehiscence

Immune-mediated encephalitis

Acute kidney injury

Nephrotic syndrome

Pneumonitis

Pulmonary embolism

Erythema multiforme

Stevens-Johnson syndrome

Small intestinal obstruction

Serositis

Immune-mediated hepatic disorder

Device related infection

Enterocolitis infectious

Sepsis

Ascites

Hypophosphataemia

Small intestinal perforation

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + Standard of Care (SOC) + MK-4830

Pembrolizumab + SOC

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Standard of Care (SOC) + MK-4830Experimental Treatment6 Interventions

Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2, carboplatin Area Under the Curve (AUC) 5 to 6, (or docetaxel 75 mg/m\^2), and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m\^2), MK-4830 800 mg, and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.

Group II: Pembrolizumab + SOCActive Control5 Interventions

Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2, carboplatin AUC 5 to 6 and (or docetaxel 75 mg/m\^2) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2, carboplatin AUC 5 to 6, (or docetaxel 75 mg/m\^2) and avastin (or biosimilar) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Pembrolizumab

FDA approved

Paclitaxel

FDA approved

Carboplatin

FDA approved

MK-4830

2022

Completed Phase 2

~160

Docetaxel

FDA approved

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, while targeted therapies, such as bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis. Immunotherapy, including PD-1 inhibitors like pembrolizumab, enhances the immune system's ability to recognize and destroy cancer cells. Immune modulation, such as the use of MK-4830, aims to alter the tumor microenvironment to make it more susceptible to immune attack. These mechanisms are crucial for ovarian cancer patients as they offer multiple avenues to combat the disease, potentially improving survival rates and quality of life by targeting cancer cells more precisely and reducing the likelihood of resistance.