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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
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 belowSelect...
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:Select...
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
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 • NCT0303810060%
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
9%
DYSGEUSIA
8%
FEBRILE NEUTROPENIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
MUCOSAL INFLAMMATION
7%
LYMPHOCYTE COUNT DECREASED
7%
HYPONATRAEMIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
PARAESTHESIA
7%
DYSPHONIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
OEDEMA PERIPHERAL
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
DRY MOUTH
5%
MALAISE
5%
DEPRESSION
5%
NASAL CONGESTION
5%
PAIN
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
INTESTINAL OBSTRUCTION
1%
LIVER INJURY
1%
PERITONITIS
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab
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 2
~2070
Computed Tomography
2017
Completed Phase 2
~2740
Carboplatin
2014
Completed Phase 3
~6120
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
891 Previous Clinical Trials
332,456 Total Patients Enrolled
8 Trials studying Ovarian Cancer
2,045 Patients Enrolled for Ovarian Cancer
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,484 Total Patients Enrolled
7 Trials studying Ovarian Cancer
505 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,978 Total Patients Enrolled
291 Trials studying Ovarian Cancer
74,941 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting time is normal or managed with medication.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I have stable brain metastases, not on steroids for 14 days, and no carcinomatous meningitis.I have not received a live vaccine within the last 30 days.I have ovarian, fallopian tube, or peritoneal cancer and have had chemotherapy including platinum-based treatment.My CA-125 levels have doubled after my recent cancer treatment.I have a history of early-stage ovarian cancer.My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.I am 18 years old or older.I have fluid buildup in my abdomen or around my lungs.I am currently being treated for an infection.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have been treated with pembrolizumab before.I have been diagnosed with HIV.I have a serious heart condition.I am fully active or restricted in physically strenuous activity but can do light work.My kidney function, measured by creatinine levels, is within the acceptable range.I have had lung inflammation that needed steroids.My cancer cannot be measured by scans and I have no symptoms from fluid build-up.I have another cancer besides skin or in situ cervical cancer that needs treatment.My CA-125 levels returned to normal after my first cancer treatment.I have severe allergies to certain cancer drugs or uncontrolled asthma.My blood clotting time is normal or managed if I'm on blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carboplatin, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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