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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Cancer

Phase 1
Recruiting
Led By Lakshmi Rajdev
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CD4 counts: For Stratum 1: CD4+ cell count greater than 200 cells/mm^3 obtained within 2 weeks prior to enrollment at any United States (U.S.) laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent For Stratum 2: CD4 cell count between 100-200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent Expansion Cohort: CD4 cell count for this cohort will be specified once Stratum 1 and Stratum 2 have completed enrollment Solid Tumor Expansion Cohort: CD4+ cell count greater than 200 cells/mm^3 obtained within 2 weeks prior to enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent cHL Cohort: CD4 cell count of at least 100 cells/mm^3 Participants must be purified protein derivative (PPD) negative; alternatively, the QuantiFERON-tuberculosis (TB) Gold In-Tube (QFT-GIT) assay can be used; an individual is considered positive for M. tuberculosis infection if the IFN-gamma response to TB antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control); the result must be obtained within 12 weeks prior to enrollment; PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment The effects of nivolumab and ipilimumab on the developing human fetus are unknown; for this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 72 hours prior enrollment and the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception; WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management; participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment Participants who have hepatitis C (both reactive anti-hepatitis C virus [HCV] antibody and detectable HCV ribonucleic acid [RNA]) and hepatitis B (hepatitis B surface antigen [HBsAg] positive and anti-hepatitis B core [HBc]-total positive), may be enrolled, provided total bilirubin is =< 1.5 x institutional ULN, and AST (SGOT) and ALT (SGPT) must be =< 3 X institutional upper limit of normal, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) < 100 IU/mL (if hepatitis B positive) within 2 weeks prior to enrollment Ability to understand and to sign a written informed consent document Criteria for Solid Tumor Expansion and Lymphoma Cohorts: Inclusion and exclusion criteria for this cohort are the same as above, with the following rule for CD4 count based on tolerability in Phase I; if, participants with lymphocyte T CD4 count between 100-200/mm^3 (Stratum 2) are shown to tolerate treatment in the Phase I dose de-escalation portion at the same dose level as those with CD4 counts > 200/mm^3 (Stratum 1), participants in the expansion cohort with CD4 counts >= 100/mm^3 are permitted; otherwise, the expansion is open to all solid tumor patients except those whose tumors are known not to respond to nivolumab (pancreas, prostate and MSS colon cancer); for the relapsed refractory HIV-cHL cohort, participants with CD4 count >= 100/mm^3 are permitted
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of two immunotherapy drugs to see if they're more effective than either drug alone in treating HIV-associated classical Hodgkin lymphoma or solid tumors.

Who is the study for?
Adults over 18 with HIV and relapsed/refractory classical Hodgkin lymphoma or metastatic/unresectable solid tumors. Must have completed certain treatments, have specific CD4 counts, not be pregnant/breastfeeding, use contraception, manage HIV effectively (including antiretrovirals), and meet blood count criteria. Excludes those previously treated with similar immunotherapies or having autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These drugs may help the immune system fight cancer by blocking proteins that control immune cell destruction. The study aims to find the best dose while observing side effects in patients with HIV-associated cancers.See study design
What are the potential side effects?
Potential side effects include inflammation in various organs, infusion reactions (like fever or chills during treatment), fatigue, digestive issues such as diarrhea or nausea, skin rashes, hormonal gland problems (like thyroid dysfunction), 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 am mostly active and can care for myself.
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My hemoglobin level is at least 9 g/dL, or it's lower due to Hodgkin lymphoma in my bone marrow.
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My bilirubin levels are within the required range for the study.
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My blood tests for lipase and amylase are below 1.5 times the upper limit.
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My kidney function is within the required range for the Hodgkin Lymphoma study.
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My HIV viral load is undetectable or very low.
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My cancer has spread, cannot be surgically removed, and standard treatments have failed.
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I have HIV-related Hodgkin lymphoma that has not improved after at least one treatment.
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I have a tumor or lesion that can be measured and was scanned within the last 4 weeks.
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I had treatment for metastatic disease, but it's been over 4 weeks since my last session.
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My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's disease.
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My white blood cell count is within the required range for the Hodgkin Lymphoma study.
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My white blood cell count is at least 1,000, unless it's low because of my lymphoma.
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I am older than 18 years.
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My platelet count is at least 75,000/mm^3 or low due to my lymphoma.
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My cancer type is not excluded from the trial based on its response to nivolumab.
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My liver function tests are within the required range for the Hodgkin Lymphoma study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 of nivolumab
Secondary outcome measures
Change in HIV viral load
Change in immune status
Immune function
+1 more
Other outcome measures
Circulating cytokine markers
HIV reactive T cells
Herpesvirus loads (Epstein-Barr virus [EBV], Kaposi sarcoma herpes virus [KSHV], cytomegalovirus [CMV]) in plasma
+6 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung abscess
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 30 minutes on day 1. Patients in dose level 2 also receive ipilimumab IV over 90 minutes on day 1 of every third cycle of nivolumab, and patients in dose level -2 also receive ipilimumab IV over 90 minutes on day 1 of every sixth cycle of nivolumab. Treatment repeats every 14 days for up to 46 cycles of nivolumab (with ipilimumab if receiving dose level 2 or -2) in the absence of disease progression or unacceptable toxicity.Patients undergo blood sample collection throughout the study. Patients undergo PET and CT scan during screening and on study. Patients undergo bone marrow biopsy on screening and may undergo it during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2014
Completed Phase 3
~2670
Positron Emission Tomography
2008
Completed Phase 2
~2260
Biospecimen Collection
2004
Completed Phase 2
~1920
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,739 Total Patients Enrolled
Lakshmi RajdevPrincipal InvestigatorAIDS Malignancy Consortium
4 Previous Clinical Trials
597 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02408861 — Phase 1
HIV/AIDS Research Study Groups: Treatment (nivolumab, ipilimumab)
HIV/AIDS Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02408861 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02408861 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographic distribution of medical institutions currently conducting this trial?

"Currently, this clinical trial is being conducted across 24 sites. Notably, the cities of Columbus, La Jolla and Bronx are all hosting study locations; other locations are available as well. If a participant chooses to enroll in the trial they should select the closest location to minimize travel requirements."

Answered by AI

What medical conditions is Ipilimumab typically employed to address?

"Typically, ipilimumab is given to patients after they have not responded well to anti-angiogenic therapy. It can also be used for conditions such as malignant neoplasms and cancerous melanomas or squamous cell carcinoma."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. Details hosted on clinicaltrials.gov demonstrate that this trial is actively searching for recruits, having been posted on August 27th 2015 and most recently updated November 29th 2022. 96 individuals are required at 24 different medical sites."

Answered by AI

Are there any additional research projects that have been conducted regarding Ipilimumab?

"In 2009, ipilimumab was first studied at Texas Children's Hospital. This drug has since been employed in 365 completed trials and is currently being tested through 764 active clinical studies; many of these experiments are located in Columbus, Ohio."

Answered by AI

To what degree can Ipilimumab be relied upon to protect patients?

"The safety of Ipilimumab was scored 1 out of 3 due to the fact that this is a Phase 1 clinical trial, indicating that there are limited data points confirming both its efficacy and safety."

Answered by AI

May individuals still apply to participate in the experiment?

"The clinical trial in question is open to applicants, as indicated by data hosted on the clinicaltrials.gov website. This research project was posted online initially on August 27th 2015 and has seen its most recent update occur November 29th 2022."

Answered by AI
~3 spots leftby Jul 2024