What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, particularly those involving Anti-PD-1 monoclonal antibodies like pembrolizumab, often result in side effects such as fatigue, skin reactions (e.g., rash, pruritus), and gastrointestinal issues (e.g., diarrhea, nausea). Severe immune-related adverse effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These treatments can also lead to general chemotherapy-related side effects such as neutropenia, anemia, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several anti-PD-1 monoclonal antibodies for various cancers, including pembrolizumab and nivolumab. Pembrolizumab, for instance, is approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. These treatments work by targeting the PD-1 pathway to enhance the immune system's ability to fight cancer. While specific approvals for pancreatic cancer may be limited, these drugs represent a broader class of immunotherapies being explored for their potential benefits in treating various malignancies, including pancreatic cancer.

What other types of research exist?

Promising alternatives to INCMGA00012 for pancreatic cancer patients include pembrolizumab (another anti-PD-1 monoclonal antibody) and combination therapies involving immune checkpoint inhibitors with chemotherapy or targeted therapies. These options have shown potential in clinical trials for various cancers and may offer new avenues for treatment.

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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

Must not have

Unhealed surgical wound or ulcer, or a non-healing bone fracture

Known history or evidence of brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Summary

This trial is testing INCMGA00012, a drug that boosts the immune system, in patients with severe pancreatic or ampullary cancer that cannot be removed by surgery or has spread. The goal is to see if this new treatment can help these patients.

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.

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.

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a wound, ulcer, or bone fracture that is not healing.

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I have or had brain metastases.

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I haven't had cancer treatment in the last 14 days.

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I haven't had major surgery in the last 4 weeks.

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I have had lung inflammation not caused by an infection.

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I have fluid buildup in the lining of my lungs that is serious or cancerous.

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I have fluid buildup in my abdomen confirmed by tests.

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I will not need any cancer treatment other than the study's while participating.

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I have been treated with immunotherapy before.

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I have had an organ or tissue transplant, including a cornea.

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All my side effects from previous cancer treatments, except for hair loss and tiredness, are mild or gone.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I have an infection with Hepatitis A, B, or C.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate (DCR) at 4 months using RECIST 1.1

Secondary study objectives

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 • NCT03019640

100%

Anemia

100%

Neutrophil count decreased

100%

White blood cell decreased

100%

Nausea

100%

Fever

100%

Lymphocyte count decreased

100%

Platelet count decreased

95%

Diarrhea

82%

Hyperglycemia

77%

Mucositis oral

77%

Fatigue

64%

Sinus tachycardia

59%

Anorexia

59%

Hypotension

55%

Rash maculo-papular

55%

Constipation

55%

Edema limbs

55%

Hypophosphatemia

50%

Headache

45%

Alanine aminotransferase increased

45%

Hypoalbuminemia

45%

Hypocalcemia

41%

Hypokalemia

41%

Dizziness

36%

Anxiety

36%

Hyponatremia

32%

Vomiting

32%

Hypertension

32%

Cough

32%

Chills

32%

Insomnia

32%

Investigations

32%

Febrile neutropenia

27%

Aspartate aminotransferase increased

27%

Alkaline phosphatase increased

27%

Pain

23%

Arthralgia

23%

Hiccups

23%

Dysphagia

23%

Esophagitis

23%

Hypomagnesemia

23%

Infections and infestations

18%

Hemorrhoids

18%

Allergic rhinitis

18%

Abdominal pain

18%

Dehydration

18%

Dyspnea

18%

Generalized muscle weakness

18%

Hypoxia

14%

Bloating

14%

Hypermagnesemia

14%

Dyspepsia

14%

Paresthesia

14%

Rectal pain

14%

Infusion related reaction

14%

Immune system disorders

14%

INR increased

14%

Pleural effusion

Arthritis

Blood bilirubin increased

Back pain

Upper respiratory infection

Cholesterol high

Bone pain

Creatinine increased

Sore throat

Dry skin

Dysgeusia

Hypernatremia

Renal and urinary disorders

Skin ulceration

Flushing

Non-cardiac chest pain

General disorders and administration site conditions

Hyperuricemia

Nasal congestion

Papulopustular rash

Hypercalcemia

Atrial fibrillation

Bladder infection

Gastrointestinal pain

Ear pain

Eye disorders

Flatulence

Nervous system disorders

Rash acneiform

Skin hyperpigmentation

Tremor

Encephalopathy

Urinary frequency

Respiratory failure

Lung

Epistaxis

Acute kidney injury

Atelectasis

Weight gain

Gastroesophageal reflux disease

Urinary tract infection

Thromboembolic event

Edema face

Endocrine disorders

Metabolism and nutrition disorders

Mucosal infection

Neck pain

Prostatic obstruction

Pulmonary edema

Hematuria

Hemorrhoidal hemorrhage

Hypoglycemia

Musculoskeletal and connective tissue disorder

Myalgia

Hypothyroidism

Lung infection

Lymph node pain

Lymphocyte count increased

Pain in extremity

Peripheral motor neuropathy

Restlessness

Sinus bradycardia

Sinusitis

Skin and subcutaneous tissue disorder

Urinary tract pain

Vascular disorders

Ileus

100%

80%

60%

40%

20%

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.

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific molecular targets involved in cancer growth. Immunotherapy, particularly anti-PD-1 monoclonal antibodies like those studied in the INCMGA00012 trial, works by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, these treatments enhance the body's immune response against cancer cells. This is significant for pancreatic cancer patients as it offers a potential avenue for treatment, especially in cases where traditional therapies have failed.