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Checkpoint Inhibitor
mRNA-2416 for Solid Tumor Malignancies or Lymphoma
Phase 1 & 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 and day 15 of cycle 1; predose on day 1 of cycles 2 and 3; predose on day 15 of cycle 3; predose on day 1 of cycles 4, 5, and 6; and end of treatment (duration of study treatment is up to 168 days)
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new cancer drug, and will specifically look at its effects in ovarian cancer patients.
Eligible Conditions
- Solid Tumor Malignancies or Lymphoma
- Ovarian Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 6 months after last mrna-2416 monotherapy dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 6 months after last mrna-2416 monotherapy dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events (AEs) and Serious AEs as Defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Objective Response Rate (ORR) Based on RECIST v1.1
Percentage of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Area Under the Serum Concentration-Time Curve (AUC) of mRNA-2416 Alone or in Combination with Durvalumab
Disease Control Rate in Participants with Ovarian Cancer (RECIST v1.1)
Duration of Response Based on RECIST v1.1
+2 moreSide 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%
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
2Treatment groups
Experimental Treatment
Group I: Arm B: mRNA-2416 in Combination with DurvalumabExperimental Treatment2 Interventions
Participants will be administered mRNA-2416 through an intratumoral injection at the applicable dose on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 in combination with durvalumab through an intravenous infusion at a fixed dose on Day 1 of Cycles 1 through 6. The duration for each cycle is 28 days.
Group II: Arm A: mRNA-2416 AloneExperimental Treatment1 Intervention
Participants will be administered mRNA-2416 through an intratumoral injection at the applicable dose on Days 1 and 15 for six 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,238 Total Patients Enrolled
Frequently Asked Questions
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