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INCB 99280 + Ipilimumab for Solid Cancers
Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have histologically confirmed solid tumors with measurable disease per RECIST v1.1
ECOG performance score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial looks at how safe and effective a new drug is when combined with an existing drug for select solid tumors.
Who is the study for?
This trial is for adults with certain solid tumors like colorectal cancer, melanoma, and kidney cancer. Participants need a confirmed diagnosis with measurable disease, an ECOG score of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but can do light work), and a life expectancy over three months. They must not be at risk of pregnancy or fathering children.Check my eligibility
What is being tested?
The study tests the combination of INCB 99280 with Ipilimumab to evaluate safety, how well it's tolerated by patients, its pharmacokinetics (how the body processes it), and effectiveness against select solid tumors. The trial has two parts: dose escalation to find the right dose and then dose expansion to test that dose more broadly.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to Ipilimumab such as inflammation in organs, skin rash, digestive issues; fatigue; changes in liver function; hormonal gland problems; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My solid tumor can be measured and has been confirmed by a biopsy.
Select...
I am fully active or can carry out light work.
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
Incidence of TEAEs
Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Occurence of DLTs
Secondary outcome measures
Concentration of INCB099280 in plasma
Disease control
Duration of Response
+1 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
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 neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
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
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab
Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab
Group II: Dose EscalationExperimental Treatment1 Intervention
Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks
Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,195 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or take more than 10 mg of steroids daily.I meet the specific treatment and diagnosis criteria for the trial phase I'm entering.I had chest radiation therapy within the last 6 months.My solid tumor can be measured and has been confirmed by a biopsy.I am not in another clinical trial while taking INCB099280.I have not received a live vaccine in the last 28 days.I have a history of lung conditions not caused by infections.I am still experiencing side effects from my previous cancer treatment.Exception Criterion: Hepatocellular carcinoma (liver cancer) may be diagnosed using specific imaging criteria.I am not taking probiotics and will not during the study.I have a stomach or intestine condition that affects how drugs are absorbed.I have brain metastases or leptomeningeal disease needing treatment.Your lab test results are not within the specified ranges as defined in the study instructions.I have had an organ or stem cell transplant.I have heart problems that affect my daily life.I am fully active or can carry out light work.I haven't taken antibiotics in the last 28 days.You have been treated for an autoimmune disease with medication that affects your entire body in the past 5 years.I have had another type of cancer in the past.I am currently being treated for an infection.The doctor thinks you will live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion
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.
Has the Federal Drug Administration sanctioned Dose Escalation?
"Due to the limited clinical data available, Dose Escalation has been rated a 1 for safety on Power's scale. This is indicative of it being in its early Phase 1 testing phase."
Answered by AI
Is there still capacity for patient enrolment in this clinical research?
"As per clinicaltrials.gov, this medical experiment is still enrolling suitable candidates. The trial was initially posted on August 30th 2023 and the most recent amendment occurred on August 21st 2023."
Answered by AI
How many participants have been accepted into this clinical experiment?
"Affirmative. According to information available on clinicaltrials.gov, the trial announced on August 30th 2023 is still recruiting participants as of its last update on August 21st 2023. A total of 100 patients are required and recruitment sites span 52 locations across America."
Answered by AI
How many venues are involved in the execution of this study?
"Patients for this trial can be enrolled at UC Irvine Medical Center in Orange, Michigan, Sharp Memorial Hospital in San Diego, Tennessee and Henry Ford Health System in Detroit, South Australia. In addition to these three sites there are 52 other locations available within the study's scope of operations."
Answered by AI
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