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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My ovarian or related cancer has returned or worsened after initial treatments.
Select...
I have measurable cancer spread in my abdomen or behind it, according to specific criteria.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT03477396100%
Alanine aminotransferase increased
100%
Cough
100%
Neutrophil count decreased
100%
Fatigue
100%
Alkaline phosphatase increased
100%
Aspartate aminotransferase increased
100%
White blood cell decreased
100%
Hyponatremia
100%
Nausea
50%
Anxiety
50%
Alopecia
50%
Vomiting
50%
Gastroesophageal reflux disease
50%
Creatinine increased
50%
Cholesterol high
50%
Dry skin
50%
Dyspnea
50%
Lymphocyte count decreased
50%
Sore throat
50%
Hot flashes
50%
Epistaxis
50%
Rash acneiform
50%
left upper eyelid droop
50%
Anorexia
50%
Constipation
50%
Dyspepsia
50%
Chills
50%
Pain
50%
Edema limbs
50%
blood in stool
50%
Upper respiratory infection
50%
Platelet count decreased
50%
Hyperglycemia
50%
Hyperkalemia
50%
Hypertriglyceridemia
50%
Hypoalbuminemia
50%
Hypoglycemia
50%
Arthralgia
50%
Osteoporosis
50%
Headache
50%
Memory impairment
50%
Depression
50%
Anemia
50%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ribociclib, Aromatase Inhibitor)
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
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,755 Total Patients Enrolled
2 Trials studying Peritoneal Carcinomatosis
51 Patients Enrolled for Peritoneal Carcinomatosis
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled
13 Trials studying Peritoneal Carcinomatosis
457 Patients Enrolled for Peritoneal Carcinomatosis
Amir A JazaeriPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
260 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but my doctor thinks it might not come back during the study.I am currently hospitalized for an infection or another serious illness.You have a platelet count of at least 100,000 per milliliter of blood.Your total bilirubin level should be no higher than 1.5 times the upper limit of normal.You have enough infection-fighting white blood cells in your body.I am willing to have biopsies before and during the treatment.You have a health condition that the doctor thinks could make it unsafe for you to take the checkpoint inhibitor treatment.I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.You have had a serious allergic reaction to a specific type of medication called biologics (monoclonal antibodies) in the past.My ovarian or related cancer has returned or worsened after initial treatments.I have high-grade ovarian, fallopian tube, or peritoneal cancer that has returned or worsened after initial treatments.I am not pregnant, cannot become pregnant, and agree to use birth control during and after the study.I have a history of autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.I have an active infection in my abdomen.I am not on more than 10 mg of prednisone daily, except for specific short-term uses.My doctor thinks I'm not fit for intraperitoneal therapy due to my medical history.It's been over 4 weeks since my last cancer treatment, or 8 weeks if it was bevacizumab.I have measurable cancer spread in my abdomen or behind it, according to specific criteria.My kidney function, measured by creatinine clearance, is adequate.My ovarian, fallopian tube, or peritoneal cancer did not respond well to platinum-based treatment.I have chronic hepatitis B or C, or I am HIV positive.Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal, unless you have bone or liver cancer, in which case they can be up to 5 times the upper limit of normal.I am fully active or restricted in physically strenuous activity but can do light work.I have cancer that has spread to my brain or surrounding membranes.I have a chronic lung condition that needs steroids, oxygen, or has led to hospital stays.My hemoglobin level is at least 9 g/dL.I have previously received immune checkpoint inhibitor therapy.I have low grade ovarian, fallopian tube, or peritoneal cancer.Your heart's QTc interval is longer than 470 milliseconds.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (nivolumab and ipilimumab)
- Group 2: Group I (nivolumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any preceding studies regarding the impact of Pharmacokinetic Study?
"Presently, 764 ongoing clinical trials are taking place in order to further research Pharmacokinetic Study; 86 of these have already reached Phase 3. Most studies pertaining to the topic take place within Pittsburgh, however there exists a total of 42751 locations conducting similar investigations."
Answered by AI
Has this Pharmacokinetic Study been sanctioned by the FDA?
"Due to the lack of clinical data validating its safety or efficacy, Pharmacokinetic Study was assigned a score of 1."
Answered by AI
Are participants currently being recruited for this experiment?
"At this juncture, the study is not actively recruiting. It was initially posted on September 21st 2018 and amended lastly on June 22nd 2022. If interested in alternate trials, 6167 studies are currently seeking patients with peritoneal carcinomatosis, while 764 clinical studies need participants for a Pharmacokinetic Study."
Answered by AI
What purpose does a Pharmacokinetic Study usually serve?
"Pharmacokinetic Study is proven to be an efficient form of therapy for pre-treated angiogenic cases, malignant tumors and inoperable melanomas."
Answered by AI
What is the cumulative enrollment of participants in this experiment?
"Unfortunately, this clinical trial is no longer enrolling participants; the study was first posted on September 21st 2018 and had its final update on June 22nd 2022. For those looking for other trials, there are 6167 studies recruiting patients with peritoneal carcinomatosis and 764 Pharmacokinetic Study opportunities that still need enrollees."
Answered by AI
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