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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Advanced Gynecologic Cancers with Peritoneal Carcinomatosis

Phase 1

Waitlist Available

Led By Amir A Jazaeri

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have biopsy-confirmed ovarian or other gynecologic cancers (fallopian tube, peritoneal, endometrial, or cervical cancer) who have recurred after or progressed on frontline and one or more second-line standard treatments

Measurable metastatic disease (by RECIST version [v] 1.1) in the peritoneal cavity or retroperitoneal lymph nodes; disease outside of the peritoneal cavity is allowed as long as metastatic sites are also present within the peritoneum/retroperitoneum

Must not have

Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization

History of cerebrovascular accident, myocardial infarction or unstable angina within the previous 6 months before starting therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of nivolumab with or without ipilimumab to treat patients with female reproductive cancer that has come back or is high grade and has spread extensively throughout the peritoneal cavity.

Who is the study for?

This trial is for women with high-grade gynecologic cancers that have returned or spread, specifically ovarian, fallopian tube, peritoneal, endometrial, or cervical cancers. Participants must have tried standard treatments without success and meet certain health criteria like blood counts and organ function. Pregnant women or those with low-grade tumors, prior immunotherapy use, autoimmune diseases, recent heart issues or severe infections are excluded.

What is being tested?

The study tests the safety and optimal doses of nivolumab alone or combined with ipilimumab in treating recurrent female reproductive cancers. These drugs are types of immunotherapy called monoclonal antibodies which may boost the immune system to fight cancer cells more effectively.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs such as the intestines (diarrhea) and liver (hepatitis), skin problems (rash), hormonal gland issues (like thyroid dysfunction), lung inflammation (pneumonitis), infusion reactions during drug administration, fatigue and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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My ovarian or related cancer has returned or worsened after initial treatments.

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I have measurable cancer spread in my abdomen or behind it, according to specific criteria.

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My kidney function, measured by creatinine clearance, is adequate.

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

Exclusion Criteria

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

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I am currently hospitalized for an infection or another serious illness.

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I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.

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I have a history of autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.

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I have an active infection in my abdomen.

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I have cancer that has spread to my brain or surrounding membranes.

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I have a chronic lung condition that needs steroids, oxygen, or has led to hospital stays.

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I have previously received immune checkpoint inhibitor therapy.

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I have low grade ovarian, fallopian tube, or peritoneal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Maximum tolerated dose (MTD)/recommended phase II dose (RP2D) of intraperitoneal (i.p.) nivolumab in combination with ipilimumab

Side effects data

From 2023 Phase 2 trial • 2 Patients • NCT03477396

100%

White blood cell decreased

100%

Nausea

100%

Fatigue

100%

Alanine aminotransferase increased

100%

Neutrophil count decreased

100%

Cough

100%

Hyponatremia

100%

Alkaline phosphatase increased

100%

Aspartate aminotransferase increased

50%

Chills

50%

Lymphocyte count decreased

50%

Platelet count decreased

50%

Vomiting

50%

Pain

50%

Hyperkalemia

50%

Hypoglycemia

50%

Arthralgia

50%

Dyspnea

50%

Epistaxis

50%

Sore throat

50%

Rash acneiform

50%

Hot flashes

50%

Edema limbs

50%

Upper respiratory infection

50%

Anorexia

50%

Hyperglycemia

50%

Memory impairment

50%

Anxiety

50%

left upper eyelid droop

50%

Dyspepsia

50%

blood in stool

50%

Hypoalbuminemia

50%

Alopecia

50%

Gastroesophageal reflux disease

50%

Depression

50%

Constipation

50%

Cholesterol high

50%

Hypertriglyceridemia

50%

Osteoporosis

50%

Headache

50%

Creatinine increased

50%

Dry skin

50%

Anemia

50%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Ribociclib, Aromatase Inhibitor)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (nivolumab and ipilimumab)Experimental Treatment4 Interventions

Patients receive nivolumab as in group I and ipilimumab i.p. on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Group I (nivolumab)Experimental Treatment3 Interventions

Patients receive nivolumab i.p. over 90 minutes on days 1, 15, and 29. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Nivolumab

2015

Completed Phase 3

~4010