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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab for Carcinoid Tumors
Phase 2
Waitlist Available
Led By Kimberly Perez, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the combination of cabozantinib and nivolumab to see if it is effective in treating advanced carcinoid tumors.
Who is the study for?
Adults with advanced carcinoid tumors that are well-differentiated and non-pancreatic in origin, who have measurable disease progression within the last year. They must have normal organ/marrow function, not be pregnant or breastfeeding, agree to use contraception, and should not have had certain treatments recently (e.g., chemotherapy within 14 days). Excluded are those with prior cabozantinib treatment, certain infections (HIV/HepBsAg/HCV), recent live vaccines, major surgery complications, brain metastases involvement or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Cabozantinib and Nivolumab for treating advanced carcinoid tumors. It aims to see how effective this drug duo is when given together compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs; high blood pressure; bleeding events; digestive issues like fistula formation or perforation; skin reactions; hormonal imbalances requiring hormone replacement therapy; fatigue and risk of infection due to immunosuppression.
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
Objective Response Rate (ORR)
Secondary outcome measures
Number of Participants with Treatment Related Adverse Events
Overall Response Rate (ORR) per immune-related response criteria
Overall survival (OS)
+1 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nivolumab and CabozantinibExperimental Treatment2 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Cabozantinib will be administered at a dose of 40mg orally, once daily
Nivolumab will be given at a dose of 240mg every 14 days, intravenously
Retreat Phase (Optional)
Participants may elect to stop nivolumab and cabozantinib with confirmed CR after at least 24 weeks of treatment.
Participants who elect to stop and then the condition progresses after stopping study treatment may be eligible to resume nivolumab and cabozantinib therapy.
This resumption will be termed as a retreatment second course phase and is available only while the study remains open and the subject meets specified criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,837 Total Patients Enrolled
6 Trials studying Carcinoid Tumor
226 Patients Enrolled for Carcinoid Tumor
Bristol-Myers SquibbIndustry Sponsor
2,636 Previous Clinical Trials
4,127,529 Total Patients Enrolled
1 Trials studying Carcinoid Tumor
9 Patients Enrolled for Carcinoid Tumor
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,556 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should be able to take oral medications in the form of pills.You cannot be currently taking any other experimental drugs.You can have received treatment with somatostatin analog before and can continue using it during the trial as long as the dosage has been the same for at least 2 months.You have an ongoing or suspected autoimmune disease, except for certain conditions like hypothyroidism that only require hormone replacement or skin disorders that don't need systemic treatment.You are taking long-term steroid or immunosuppressive medication for a medical condition, except for adrenal replacement therapy in the absence of autoimmune disease.You have not received any chemotherapy treatment for at least 14 days before starting the study.You currently have an infection that needs to be treated with intravenous (IV) antibiotics.You must stop taking any biologic medications at least 28 days before the study. If the medication has a short half-life, the duration may be shortened to 14 days.You can join the trial if you had a treatment to block or destroy blood vessels going to your liver, but only if the disease has spread beyond the treated area or if there is evidence of the disease getting worse in the treated area. You must have completed this treatment at least 28 days before joining the trial.If you have had radiation therapy before, it must have ended within a certain period of time before you can participate in the study.You have a type of cancer called a well-differentiated neuroendocrine tumor that has spread to other parts of your body and cannot be removed by surgery. This type of cancer is not located in the pancreas, but instead is called a carcinoid.You have a tumor or lesion that can be measured to be at least 2 cm with standard methods or 1 cm with advanced imaging techniques like CT or MRI.You must have had an increase in the size or spread of your disease on a medical imaging test within the past year.You have already received treatment for your condition, including somatostatin analog therapy, and have recovered from any side effects.If you have received radiation treatment with somatostatin analogs, you need to wait at least 6 weeks before joining the study.If you have had a procedure to block or destroy blood vessels in your liver before, you can still participate if your cancer has grown outside of the treated area or if the cancer in the treated area has gotten worse. The procedure must have been done at least 28 days before you join the study.You have had an allergic reaction to drugs that are similar to cabozantinib or nivolumab in the past.You have a digestive disorder that may cause the formation of abnormal connections between organs or perforation such as tumors in the digestive tract, active ulcers or inflammation in the bowels, or blockages in the stomach or intestines. You also have had any damage or abscesses in the abdomen within the last six months.If you have had cancer in the past, you may still qualify if you have been cancer-free for at least 3 years or if your doctor thinks you are not likely to get cancer again.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab and Cabozantinib
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.
Does Cabozantinib have any dangerous side effects?
"Given that this is a phase 2 trial, there is some data supporting Cabozantinib's safety but none yet for its efficacy. Our team gives it a score of 2."
Answered by AI
Are we currently looking for more test subjects for this experiment?
"This particular clinical trial is not admitting any more patients at this time. It was originally posted on December 26th, 2019 and updated for the last time on October 24th, 2020. However, there are presently 2677 other trials actively recruiting patients with neuroendocrine tumors and 830 different trials involving Cabozantinib that are accepting participants."
Answered by AI
What are some of the approved indications for Cabozantinib?
"Cabozantinib is most often used as an anticancer medication. However, it can also be effective in treating unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Are there previous studies that suggest Cabozantinib is effective?
"Currently, there are 830 ongoing clinical studies for the drug cabozantinib. Of these trials, 92 are in phase 3. Many of the trials are based in Basel, Switzerland; however, there are 43914 locations around the world where clinical trials for cabozantinib are taking place."
Answered by AI
Is this research breaking new ground?
"There are 830 ongoing studies for Cabozantinib in 54 countries and 2596 cities. The first ever clinical trial was completed in 2010 by Medarex and only involved 127 patients. It went through Phase 1 of drug approval. In the last 10 years, there have been 302 additional trials."
Answered by AI
How many test subjects are part of this experiment?
"As of right now, this study is not looking for any more participants. However, this could change in the future as the study was last updated on October 24th, 2022. If you are interested in other studies, 2677 trials are currently recruiting patients with neuroendocrine tumors and 830 studies involve Cabozantinib."
Answered by AI
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