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Alkylating agents

Pembrolizumab + Carboplatin for Recurrent Gynecologic Cancer

Phase 2

Recruiting

Led By John B. Liao

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy

CA-125 increased to more than twice the upper limit of normal or two times the nadir value after most recent second or later line of treatment

Must not have

Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed

History of borderline or low malignant potential ovarian cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab + carboplatin to treat ovarian, fallopian tube, or primary peritoneal cancer that has come back.

Who is the study for?

This trial is for patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who've had platinum-based chemo. They must have a certain level of CA-125 antigen and no measurable disease by specific criteria. Participants need to be sexually active individuals agreeing to contraception, have a life expectancy over 3 months, good performance status (0 or 1), and meet blood count and organ function requirements.

What is being tested?

The trial tests pembrolizumab (an immunotherapy drug) combined with carboplatin (a chemotherapy drug) on patients whose cancer has returned. Pembrolizumab may boost the immune system's attack on cancer cells while carboplatin aims to stop tumor growth by killing cells or preventing their division.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs' components, fatigue from treatment, potential damage to organs due to inflammation caused by pembrolizumab, as well as typical chemotherapy-related issues like nausea, hair loss, nerve damage (neuropathy), and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have ovarian, fallopian tube, or peritoneal cancer and have had chemotherapy including platinum-based treatment.

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My CA-125 levels have doubled after my recent cancer treatment.

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I am 18 years old or older.

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

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My CA-125 levels returned to normal after my first cancer treatment.

Exclusion Criteria

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

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I have not received a live vaccine within the last 30 days.

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I have a history of early-stage ovarian cancer.

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I have fluid buildup in my abdomen or around my lungs.

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I am currently being treated for an infection.

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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 haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

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I have been treated with pembrolizumab before.

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I have been diagnosed with HIV.

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I have a serious heart condition.

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I have had lung inflammation that needed steroids.

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I have severe allergies to certain cancer drugs or uncontrolled asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Changes in T cell activation

PD-L2 expression

Programmed cell death ligand 1 (PD-L1) expression

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100

60%

ALOPECIA

51%

NAUSEA

45%

ARTHRALGIA

44%

ANAEMIA

38%

FATIGUE

35%

CONSTIPATION

35%

DIARRHOEA

35%

HYPERTENSION

30%

NEUTROPENIA

28%

ABDOMINAL PAIN

28%

NEUTROPHIL COUNT DECREASED

28%

PERIPHERAL SENSORY NEUROPATHY

24%

NEUROPATHY PERIPHERAL

24%

RASH

23%

VOMITING

23%

HEADACHE

22%

WHITE BLOOD CELL COUNT DECREASED

22%

MYALGIA

21%

PLATELET COUNT DECREASED

21%

PROTEINURIA

21%

EPISTAXIS

21%

THROMBOCYTOPENIA

19%

DECREASED APPETITE

18%

HYPOTHYROIDISM

17%

URINARY TRACT INFECTION

16%

PYREXIA

16%

COUGH

15%

STOMATITIS

14%

ALANINE AMINOTRANSFERASE INCREASED

14%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

HYPOMAGNESAEMIA

14%

BACK PAIN

14%

INSOMNIA

14%

DYSPNOEA

14%

PRURITUS

13%

WEIGHT DECREASED

13%

PAIN IN EXTREMITY

12%

ASTHENIA

12%

INFUSION RELATED REACTION

12%

DIZZINESS

11%

LEUKOPENIA

11%

HYPOKALAEMIA

10%

UPPER RESPIRATORY TRACT INFECTION

DYSGEUSIA

FEBRILE NEUTROPENIA

ABDOMINAL PAIN UPPER

HYPOAESTHESIA

WEIGHT INCREASED

HYPERTHYROIDISM

MUCOSAL INFLAMMATION

LYMPHOCYTE COUNT DECREASED

HYPONATRAEMIA

BONE PAIN

MUSCULAR WEAKNESS

PARAESTHESIA

DYSPHONIA

OROPHARYNGEAL PAIN

DYSPEPSIA

RASH MACULO-PAPULAR

HYPERGLYCAEMIA

OEDEMA PERIPHERAL

BLOOD ALKALINE PHOSPHATASE INCREASED

NASOPHARYNGITIS

ABDOMINAL DISTENSION

ANXIETY

DRY MOUTH

MALAISE

DEPRESSION

NASAL CONGESTION

PAIN

VISION BLURRED

DRY SKIN

URTICARIA

HOT FLUSH

NECK PAIN

GASTROOESOPHAGEAL REFLUX DISEASE

ILEUS

PNEUMONIA

PULMONARY EMBOLISM

COLITIS

SMALL INTESTINAL OBSTRUCTION

INTESTINAL OBSTRUCTION

LIVER INJURY

PERITONITIS

UROSEPSIS

DEHYDRATION

TRANSIENT ISCHAEMIC ATTACK

PNEUMONITIS

ABDOMINAL ABSCESS

INFECTED LYMPHOCELE

PYELONEPHRITIS

100%

80%

60%

40%

20%

Study treatment Arm

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin, pembrolizumab)Experimental Treatment5 Interventions

Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Computed Tomography

2017

Completed Phase 2

~2740