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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 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 3 trial • 867 Patients • NCT0308447126%
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%
Arthralgia
7%
Hypothyroidism
7%
Haematuria
7%
Abdominal pain
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Pneumonia
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3750
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
118 Previous Clinical Trials
61,585,105 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,522 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid function is normal, or I have stable hypothyroidism with proper treatment.I have not had radiotherapy or cancer treatment in the last 14 days.I do not have an active infection like TB, hepatitis B, hepatitis C, or HIV.I do not have any serious ongoing illnesses that would affect my participation in the study.I have used immunosuppressive medication within the last 14 days.I weigh more than 30 kilograms.I have or had an autoimmune or inflammatory disorder.I can and am willing to provide tumor samples for biopsy if it's safe.I am on blood thinners and will be during my tumor injection or biopsy.I have a lasting side effect that won't worsen with durvalumab, confirmed by a medical expert.My advanced cancer has at least one tumor that can be measured.I have active bleeding in my GI tract or lungs, or a history of bleeding disorders.I have moderate to severe nerve pain or damage.You have a history of a weak immune system, receiving an organ transplant from someone else, or having had tuberculosis.I have not received a live vaccine in the last 30 days.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I have active brain tumors or cancer that has spread to my brain.I haven't had cancer treatment or investigational drugs within the last 28 days or 5 half-lives, whichever is shorter.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I am not pregnant, breastfeeding, and willing to use birth control during and up to 120 days after the study.I am post-menopausal or not pregnant if pre-menopausal.My blood and organ functions are within normal ranges.I can carry out all my self-care activities and haven't gotten worse in the past 2 weeks.My cancer has worsened despite treatment, or I cannot tolerate/choose not to have standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: mRNA-2752
- Group 2: Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab
- Group 3: Arm B: mRNA-2752 + Durvalumab
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.
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