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Checkpoint Inhibitor

Immunotherapy with TLR Agonist for Cancer

Phase 1

Waitlist Available

Led By David S. Hong, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist

ECOG performance status </= 2 (Karnofsky >60%)

Must not have

History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation

Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (when used in the management of cancers other than intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma, or when used to treat non-cancer-related illnesses)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination cancer therapy to see if it is safe and effective.

Who is the study for?

Adults with advanced solid tumors that standard therapy has failed to cure or for which no standard treatment exists can join this trial. They must have been off other treatments for at least 4 weeks, have a stable health status, and agree to use contraception. People with severe allergies to the study drugs, recent vaccines, certain infections or diseases like severe autoimmune disorders cannot participate.

What is being tested?

The trial is testing the highest dose of MGN1703 (not FDA approved) that's safe when given with ipilimumab (FDA approved for melanoma) in patients with advanced tumors. Researchers want to see how well these two drugs work together and what side effects they might cause.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells in various organs, allergic reactions specific to drug components, fatigue, digestive issues such as bowel inflammation or perforation, skin conditions like rash or itching, and potential hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread, and standard treatments haven't worked or aren't available.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had serious gut issues like diverticulitis or blockages.

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I am not currently on treatments like IL-2, interferon, chemotherapy, or long-term steroids for non-cancer conditions.

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I am not pregnant or breastfeeding and agree to use contraception during the study.

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I have been treated with TLR agonist therapy before.

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I haven't had major surgery or a serious injury in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) of MGN1703 with Ipilimumab

Secondary study objectives

Tumor Response

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: MTD Post XRT Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions

Dose expansion group consists of participants with advanced malignancy treated with radiation (XRT) within the past 2 weeks. MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.

Group II: MTD Group: MGN1703 (subcutaneously) + IpilimumabExperimental Treatment2 Interventions

Dose expansion group consists of participants with advanced malignancy and cutaneous or subcutaneous manifestations. MGN1703 given subcutaneously at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.

Group III: MTD Group: MGN1703 (intratumoral injection) + IpilimumabExperimental Treatment2 Interventions

Dose expansion group consists of participants with advanced malignancy and cutaneous or or subcutaneous manifestations. MGN1703 given by intratumoral injection at MTD from the Dose Escalation Group. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long.

Group IV: Dose Escalation Group: MGN1703 + IpilimumabExperimental Treatment2 Interventions

Participants receive MGN1703 on Days 1, 8, and 15 of all cycles as an injection under the skin. Ipilimumab dosed at 3 mg/kg once per cycle on Day 8 following MGN1703 administration. Each cycle is 21 days long. Participants receive a total of 4 treatment cycles for a total of 12 weeks on treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MGN1703

2014

Completed Phase 2

~180

Ipilimumab

2015

Completed Phase 3

~3070