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Virus Therapy

mRNA-2752 + Durvalumab for Advanced Cancers

Phase 1
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a body weight of >30 kilograms (kg)
Histologically confirmed advanced or metastatic disease with at least 1 measurable lesion as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Cheson 2016 criteria
Must not have
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the participant to give written informed consent
Any active or prior documented autoimmune or inflammatory disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial will test how well a new drug works in people with cancer that has returned or does not respond to treatment.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors or lymphoma, weighing over 30 kg, who have progressed after standard treatments. They must be clinically stable, able to provide tumor biopsies, and not pregnant. Exclusions include recent radiotherapy, active bleeding disorders, immunosuppressive drug use within 14 days prior to treatment start, autoimmune/inflammatory disorders history, major surgery within the past month or minor procedures in the last week.Check my eligibility
What is being tested?
The study tests escalating doses of mRNA-2752 injected directly into tumors alongside Durvalumab in patients with relapsed/refractory cancers. It aims to determine safety and tolerability while observing any potential therapeutic effects on various types of cancerous growths.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, general symptoms like fatigue and fever due to immune activation by Durvalumab; organ inflammation; increased risk of infections; possible exacerbation of pre-existing autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 30 kilograms.
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My advanced cancer has at least one tumor that can be measured.
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I am post-menopausal or not pregnant if pre-menopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious ongoing illnesses that would affect my participation in the study.
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I have or had an autoimmune or inflammatory disorder.
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I am on blood thinners and will be during my tumor injection or biopsy.
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I have active bleeding in my GI tract or lungs, or a history of bleeding disorders.
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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.
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I have active brain tumors or cancer that has spread to my brain.
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I haven't had cancer treatment or investigational drugs within the last 28 days or 5 half-lives, whichever is shorter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm B: Overall Response Rate (ORR): Percentage of Participants with Tumor Response (Partial or Complete) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) in Cutaneous Melanoma
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
ORR: Percentage of Participants with Tumor Response (Partial or Complete) Based on RECIST v1.1 and modified RECIST (iRECIST), and Cheson and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) for Participants With Lymphoma
Pharmacokinetics: Maximum Observed Concentration (Cmax)

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: mRNA-2752 Alone or mRNA-2752 + DurvalumabExperimental Treatment2 Interventions
Participants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab.
Group II: Arm B: mRNA-2752 + DurvalumabExperimental Treatment2 Interventions
Participants will be administered mRNA-2752 at an applicable dose in combination with durvalumab.
Group III: Arm A: mRNA-2752Experimental Treatment1 Intervention
Participants will be administered mRNA-2752 at an applicable dose as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,830 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,624,465 Total Patients Enrolled

Media Library

mRNA-2752 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03739931 — Phase 1
Dose Escalation Research Study Groups: Arm A: mRNA-2752, Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab, Arm B: mRNA-2752 + Durvalumab
Dose Escalation Clinical Trial 2023: mRNA-2752 Highlights & Side Effects. Trial Name: NCT03739931 — Phase 1
mRNA-2752 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739931 — Phase 1
~29 spots leftby Mar 2026
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