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Checkpoint Inhibitor
Nivolumab + Ipilimumab for Salivary Gland Cancer
Phase 2
Waitlist Available
Led By Alan Ho, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0 or 1 (or Karnofsky ≥ 70%).
Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test the effects of nivolumab and ipilimumab on patients with salivary cancer.
Who is the study for?
Adults with confirmed salivary gland cancer, except adenoid cystic carcinoma, can join this trial. They must have measurable disease and be in good physical condition (able to perform daily activities or only limited help needed). Participants need proper organ function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no recent high-dose steroids or immune diseases.Check my eligibility
What is being tested?
The study is testing the combination of two immunotherapy drugs called Nivolumab and Ipilimumab on patients with salivary gland cancer. It aims to discover the positive and negative effects these drugs may have on participants' health and their cancer.See study design
What are the potential side effects?
Nivolumab and Ipilimumab might cause fatigue, skin reactions, digestive issues like diarrhea, liver inflammation which could affect blood tests results; lung problems that can make breathing difficult; hormone gland problems like thyroid disorders; kidney issues including possible failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or able to carry out light work.
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My cancer has returned or spread and cannot be removed by surgery or cured with radiation.
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I am 18 years old or older.
Select...
I have been diagnosed with salivary gland cancer, not adenoid cystic carcinoma.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
best overall response rate
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: R/M adenoid cystic carcinoma (ACC)Experimental Treatment2 Interventions
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Group II: R/M SGC of any histology, except ACC (Non ACC)Experimental Treatment2 Interventions
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,450 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,556 Total Patients Enrolled
Alan Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
213 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, based on my age, weight, and creatinine levels, is suitable.My cancer has worsened or spread in the last 6 months, as shown by scans or symptoms.I am fully active or able to carry out light work.You have had a serious allergic reaction to any type of antibody medication in the past.I finished my last cancer treatment at least 2 weeks ago and have recovered from side effects.I haven't taken high doses of steroids or other immune-weakening medicines in the last 2 weeks.I am currently on hormonal therapy and can continue it during the trial.I agree to have two biopsies unless it's unsafe or not possible for me.I am using birth control to prevent pregnancy during and after the trial.I am a woman of childbearing potential not surgically sterilized or menopausal.My cancer has returned or spread and cannot be removed by surgery or cured with radiation.I am 18 years old or older.I do not have an active hepatitis B or C infection.I have been diagnosed with salivary gland cancer, not adenoid cystic carcinoma.I am not pregnant or breast-feeding.My kidney function, measured by creatinine levels, is within the normal range.I am a woman who can have children and have a negative pregnancy test.I have an autoimmune disease, but it's controlled or one of the exceptions listed.I have not received treatments targeting immune checkpoints.I have a confirmed diagnosis of adenoid cystic carcinoma.I can provide tissue samples from my cancer for study.My kidney function, based on my age, weight, and creatinine levels, is adequate.I am a man who will use contraception during and after the study, unless I am sterile or cannot produce sperm.I do not have symptoms from brain or spinal cord tumor spread.
Research Study Groups:
This trial has the following groups:- Group 1: R/M adenoid cystic carcinoma (ACC)
- Group 2: R/M SGC of any histology, except ACC (Non ACC)
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.
What are the most common indications for Nivolumab?
"Nivolumab has shown to be effective in the treatment of previous anti-angiogenic therapies, as well as other conditions such as malignant neoplasms and unresectable melanoma."
Answered by AI
What is the maximum dosage of Nivolumab that has been found to be safe for patients?
"Nivolumab's safety is based on Phase 2 data, which suggests that while there are no guarantees of efficacy, the medication appears to be safe."
Answered by AI
What are some other times Nivolumab has been used in medical research?
"As of right now, there are 796 ongoing clinical trials for the use of Nivolumab. Out of these, 86 are in Phase 3. It's worth mentioning that many of these Nivolumab trials take place in Pittsburgh, Pennsylvania; however, 43299 locations around the world are running similar studies."
Answered by AI
Can people with the qualifying medical condition participate in this trial right now?
"The clinical trial in question is no longer recruiting patients, as reflected by the information found on clinicaltrials.gov. This particular study was posted on 5/26/2017 and updated for the last time on 6/1/2022. There are 830 other medical trials that are still looking for participants."
Answered by AI
How many people are currently involved in this clinical trial?
"This particular trial is not currently searching for new patients, as the last update was on June 1st, 2022. However, there are 34 other trials involving salivary gland cancer and 796 studies that use Nivolumab recruiting right now."
Answered by AI
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