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Monoclonal Antibodies
PD-1 Inhibitor for Pancreatic Cancer
Phase 2
Recruiting
Led By Nilofer Azad, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can shrink or stop the growth of adenosquamous pancreatic or ampullary cancer that can't be removed by surgery or has spread to other parts of the body.
Who is the study for?
This trial is for adults with advanced pancreatic or ampullary cancer that can't be surgically removed. Participants must have tried at least one chemotherapy, be in fairly good health (ECOG 0-1), and not have had more than two systemic treatments. They should expect to live more than three months, agree to biopsies, use birth control if applicable, and sign consent forms. People with certain medical conditions or recent treatments are excluded.Check my eligibility
What is being tested?
The study tests INCMGA00012 (a PD-1 antibody) on patients who've previously treated their unresectable or metastatic adenosquamous pancreatic or ampullary cancer without success. It's a Phase 2 trial focusing on the effectiveness of this immunotherapy drug.See study design
What are the potential side effects?
While specific side effects for INCMGA00012 aren't listed here, PD-1 antibodies typically may cause immune-related reactions affecting organs like lungs and intestines, skin issues, fatigue, hormonal changes, flu-like symptoms and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 1 or 2 treatments for my condition, including chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a specific type of pancreas or ampulla cancer.
Select...
I am HIV-positive, on effective treatment, with a CD4+ count ≥ 350 and an undetectable viral load.
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I will use an approved method of birth control during the study.
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My organ and bone marrow functions meet the required levels for the study.
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I am 18 years old or older.
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My cancer cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate (DCR) at 4 months using RECIST 1.1
Secondary outcome measures
Disease
Number of participants experiencing study drug-related toxicities
Number of subjects with partial response (PR) or complete response (CR)
Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
1Treatment groups
Experimental Treatment
Group I: INCMGA00012 (PD-1 antibody)Experimental Treatment1 Intervention
All participants will receive the interventional study drug; INCMGA00012.
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,895 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,980 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 1 or 2 treatments for my condition, including chemotherapy.My cancer is a specific type of pancreas or ampulla cancer.I am HIV-positive, on effective treatment, with a CD4+ count ≥ 350 and an undetectable viral load.I have a wound, ulcer, or bone fracture that is not healing.I agree to have two tumor biopsies: one now and another during treatment.I am not pregnant and will follow the study's birth control requirements.You are using extra oxygen at home.I have or had brain metastases.I haven't had cancer treatment in the last 14 days.I haven't had major surgery in the last 4 weeks.I will use an approved method of birth control during the study.My organ and bone marrow functions meet the required levels for the study.You have at least one spot of the disease that can be measured.I am fully active or restricted in physically strenuous activity but can do light work.I have been on systemic immunosuppressants for an autoimmune disease in the last 2 years.I am unable to follow the study's schedule.I am 18 years old or older.I have had lung inflammation not caused by an infection.You regularly use illegal drugs or abuse other substances.I have not taken any steroids in the last 14 days.You have had a bad reaction to any type of monoclonal antibody.I have fluid buildup in the lining of my lungs that is serious or cancerous.I have fluid buildup in my abdomen confirmed by tests.I will not need any cancer treatment other than the study's while participating.I have been treated with immunotherapy before.I have had an organ or tissue transplant, including a cornea.I have not received a live vaccine in the last 28 days.My cancer cannot be removed by surgery and has spread.You are expected to live for more than 3 months.All my side effects from previous cancer treatments, except for hair loss and tiredness, are mild or gone.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.Your oxygen level is less than 92% when measured with a device on your finger.I have an infection with Hepatitis A, B, or C.I have a serious heart condition.Your blood albumin level is below 2.8 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: INCMGA00012 (PD-1 antibody)
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 potential hazards are associated with utilizing INCMGA00012 (PD-1 antibody) for patients?
"Our experts at Power have rated the safety of INCMGA00012 (PD-1 antibody) as a 2, due to Phase 2 trial results indicating evidence for safe use but no efficacy data."
Answered by AI
Is this an unprecedented clinical trial?
"Incyte Corporation sponsored the initial research for INCMGA00012 (PD-1 antibody) in 2016, with a cohort of 325 participants. Following its Phase 1 approval, today there are 26 active studies spanning 43 countries and 117 cities that investigate the use of this medication."
Answered by AI
What is the current size of the cohort participating in this investigation?
"Affirmative. The details on clinicaltrials.gov verify that, since April 9th 2020, this experiment has been actively recruiting 25 participants across 2 medical facilities. The trial was last modified on August 16th 2022."
Answered by AI
Are any new participants being admitted to this clinical investigation?
"This experiment, originally advertised on April 9th 2020, is presently accepting participants. It has been recently updated as of August 16th 2022 according to clinicaltrials.gov."
Answered by AI
What past experiments have been conducted to investigate the effects of INCMGA00012 (PD-1 antibody)?
"At this moment, 26 studies are taking place in relation to INCMGA00012 (PD-1 antibody), with 3 of them presently at Phase 3. The majority of clinical trials for this treatment occur in A CORU�A and Virginia; however, the research is being conducted across 810 different locations globally."
Answered by AI
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