NCT02151448 · OUTCOME

Recommended Phase 2 Dose (RP2D) (Phase 1)

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies · Source last updated 2020-07-20

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 24 weeks

What was measured

Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study.

Analysis population: Only includes patients participating in the Phase 1 portion.

Groups in this outcome

Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen

α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)

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

Analysis denominator · Participants

Group	Source count
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen	9

Reported measurements

Source class 1

5 MU/M^2IFN alpha

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen	5	Not reported	Not reported	Not reported	Not reported

10 MU/M^2 IFN alpha

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen	0	Not reported	Not reported	Not reported	Not reported

20 MU/M^2IFN alpha (RP2D)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
title
5 MU/M^2IFN alpha
measurements
group Id
OG000
value
0
title
10 MU/M^2 IFN alpha
measurements
group Id
OG000
value
4
title
20 MU/M^2IFN alpha (RP2D)

denoms

counts
group Id
OG000
value
9
units
Participants

description

Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2) during the Phase 1 portion of the study.

groups

description
α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon α -2b: Intravenous infusion - 5 MU/m\^2, 10 MU/m\^2 or 20 MU/m\^2 (T-Fri)
id
OG000
title
Phase 1- αDC1 Vaccine +1 Cycle of Chemokine Modulatory Regimen

param Type

COUNT_OF_PARTICIPANTS

population Description

Only includes patients participating in the Phase 1 portion.

reporting Status

POSTED

time Frame

Up to 24 weeks

title

Recommended Phase 2 Dose (RP2D) (Phase 1)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice