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NCT03948763 · OUTCOME

T-cell Receptor (TCR) Clonality and Diversity

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) · Source last updated 2025-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to approximately 24 months

What was measured

TCR clonality and diversity in the periphery and tumor.

Analysis population: Data were not collected for this outcome measure.

Groups in this outcome

Part 1: V941 Monotherapy

V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles

Part 1: V941 + Pembrolizumab

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles

Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)

V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: V941 Monotherapy0
Part 1: V941 + Pembrolizumab0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    units
    Participants
description
TCR clonality and diversity in the periphery and tumor.
groups
  1. description
    V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
    id
    OG000
    title
    Part 1: V941 Monotherapy
  2. description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
    id
    OG001
    title
    Part 1: V941 + Pembrolizumab
  3. description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    OG002
    title
    Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
  4. description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    OG003
    title
    Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
  5. description
    V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
    id
    OG004
    title
    Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
population Description
Data were not collected for this outcome measure.
reporting Status
POSTED
time Frame
Up to approximately 24 months
title
T-cell Receptor (TCR) Clonality and Diversity
type
OTHER_PRE_SPECIFIED

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice