Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05155254
Registration number
NCT05155254
Ethics application status
Date submitted
30/11/2021
Date registered
13/12/2021
Date last updated
9/01/2024
Titles & IDs
Public title
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
Query!
Scientific title
An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)
Query!
Secondary ID [1]
0
0
2021-004594-32
Query!
Secondary ID [2]
0
0
IO102-IO103-013 / KEYNOTE-D18
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - IO102-IO103
Treatment: Drugs - Pembrolizumab
Experimental: IO102-IO103 + pembrolizumab - IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment).
Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
Active Comparator: pembrolizumab - Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).
Treatment: Drugs: IO102-IO103
IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously
Treatment: Drugs: Pembrolizumab
Pembrolizumab administered intravenously
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS defined as the time from randomization to the first documented disease progression ((based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause.
Query!
Timepoint [1]
0
0
Approximately 3.5 years
Query!
Secondary outcome [1]
0
0
Overall Response Rate (ORR)
Query!
Assessment method [1]
0
0
ORR defined as the percentage of patients achieving a confirmed PR or CR. ORR will be determined by an IRC in accordance with RECIST v1.1.
Query!
Timepoint [1]
0
0
Approximately 2.5 years
Query!
Secondary outcome [2]
0
0
Overall survival (OS)
Query!
Assessment method [2]
0
0
OS defined as the time from randomisation until death from any cause. months. This will be determined by an IRC in accordance with RECIST v1.1.
Query!
Timepoint [2]
0
0
Approximately 5.5 years
Query!
Secondary outcome [3]
0
0
Durable Objective response rate (DRR)
Query!
Assessment method [3]
0
0
DRR is defined as the percentage of patients achieving a PR or CR > 6 months. This will be determined by an IRC in accordance with RECIST v1.1.
Query!
Timepoint [3]
0
0
Approximately 3.5 years
Query!
Secondary outcome [4]
0
0
Complete response rate (CRR)
Query!
Assessment method [4]
0
0
Percentage of patients with a visit response of CR, which will be determined by the IRC in accordance with RECIST v1.1.
Query!
Timepoint [4]
0
0
Approximately 3.5 years
Query!
Secondary outcome [5]
0
0
Duration of response (DoR)
Query!
Assessment method [5]
0
0
DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier) (based on IRC).
Query!
Timepoint [5]
0
0
Approximately 3.5 years
Query!
Secondary outcome [6]
0
0
Time to response (TTR)
Query!
Assessment method [6]
0
0
TTR is defined as the time from the date of randomization to the date of first observed PR or CR (based on IRC).
Query!
Timepoint [6]
0
0
Approximately 3.5 years
Query!
Secondary outcome [7]
0
0
Time to complete response (TTCR)
Query!
Assessment method [7]
0
0
TTCR is defined as the time from the date of randomization to the date of first observed CR (based on IRC).
Query!
Timepoint [7]
0
0
Approximately 3.5 years
Query!
Secondary outcome [8]
0
0
Disease control rate (DCR)
Query!
Assessment method [8]
0
0
DCR is defined as the percentage of patients achieving a PR or CR or SD (based on IRC).
Query!
Timepoint [8]
0
0
Approximately 3.5 years
Query!
Secondary outcome [9]
0
0
Incidence of e.g. AEs and SAEs (Safety and Tolerability)
Query!
Assessment method [9]
0
0
Incidence of AEs and SAEs, and treatment related AEs and SAEs. Incidence of AEs causing discontinuation of trial treatment.
Query!
Timepoint [9]
0
0
Approximately 3.5 years
Query!
Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed stage III (unresectable) or stage IV
melanoma, as per American Joint Committee on Cancer 8th edition guidelines not
amenable to local therapy
2. Patients are treatment naive, that is, no previous systemic anticancer therapy for
unresectable or metastatic melanoma. For clarification, the following patients are
eligible:
1. Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive
and without rapidly progressive disease as per investigators assessment.
Documented BRAF V600 mutation status must be available from all patients prior to
trial entry.
2. Patients who have received previous adjuvant and/or neoadjuvant therapy with
targeted therapy or immune therapy are eligible if administered the last dose at
least 6 months before inclusion in this trial (randomization), and if relapse did
not occur during active treatment or within 6 months of treatment
discontinuation.
3. At least 1 measurable lesion according to response evaluation criteria for solid
tumors (RECIST v1.1) and confirmed by IRC.
4. Provision of archival (obtained within 3 months), or newly acquired biopsy tissue not
previously irradiated, and blood at screening for biomarker assessments.
Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly
obtained biopsies are preferred to archived tissue.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Patients with known or suspected central nervous system (CNS) metastases or with the
CNS as the only site of active disease are excluded with the following exception:
• Patients with controlled (stable) brain metastases will be allowed to enroll
(subject to baseline magnetic resonance imaging (MRI) confirmation). Controlled
(stable) brain metastases are defined as those with no radiographic progression for at
least 4 weeks after radiation and/or surgical treatment at the time of signed informed
consent. Patients must have been off steroids for at least 2 weeks before signed
informed consent and have no new or progressive neurological signs and symptoms.
2. Patient has received previous radiotherapy within 2 weeks of start of trial treatment
(visit 2). Patients must have recovered from all radiation-related toxicities, not
require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is
permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
3. Patients with BRAFV600-positive disease who are experiencing rapidly progressing
disease and/or have received standard first-line therapy with BRAF and/or MEK
inhibitor for unresectable or metastatic disease.
Other protocol defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/05/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/09/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
407
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Query!
Recruitment hospital [1]
0
0
Border Medical Oncology Research Unit - Albury
Query!
Recruitment hospital [2]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [3]
0
0
Southern Medical Day Care Centre - Wollongong
Query!
Recruitment hospital [4]
0
0
Cairns Hospital - Cairns
Query!
Recruitment hospital [5]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [6]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [7]
0
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [8]
0
0
Peter MacCallum Cancer Centre PMCC - East Melbourne - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2640 - Albury
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
4870 - Cairns
Query!
Recruitment postcode(s) [5]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [6]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [7]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [8]
0
0
3052 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
New York
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Virginia
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Oost-Vlaanderen
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Sint-Niklaas
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Hradec Králové
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Olomouc
Query!
Country [8]
0
0
Czechia
Query!
State/province [8]
0
0
Ostrava
Query!
Country [9]
0
0
Czechia
Query!
State/province [9]
0
0
Praha
Query!
Country [10]
0
0
Denmark
Query!
State/province [10]
0
0
Aalborg
Query!
Country [11]
0
0
Denmark
Query!
State/province [11]
0
0
Aarhus
Query!
Country [12]
0
0
Denmark
Query!
State/province [12]
0
0
Herlev
Query!
Country [13]
0
0
Denmark
Query!
State/province [13]
0
0
Odense
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Besancon
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bordeaux
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Boulogne Billancourt
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Dijon
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
La Tronche
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Lille
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Marseille cedex 05
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Nice
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Pierre Benite
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rennes Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Saint Herblain
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Valence
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Villejuif Cedex
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Augsburg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Berlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Bochum
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Erlangen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Essen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Frankfurt
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Halle (Saale)
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Hamburg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Heidelberg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Heilbronn
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Kiel
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Mainz
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Mannheim
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Minden
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Muenchen
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Münster
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Tubingen
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Wuerzburg
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Budapest
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Pecs
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Szolnok
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Afula
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Beer Sheva
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Jerusalem
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Petah Tikva
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Tel Aviv-Yafo
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Tel Hashomer
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Ancona
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Aviano
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Bari
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Candiolo
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Genova
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Meldola
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Milano
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Napoli
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Padova
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Perugia
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Roma
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Rome
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Siena
Query!
Country [67]
0
0
Netherlands
Query!
State/province [67]
0
0
Amsterdam
Query!
Country [68]
0
0
Netherlands
Query!
State/province [68]
0
0
Leiden
Query!
Country [69]
0
0
Netherlands
Query!
State/province [69]
0
0
Maastricht
Query!
Country [70]
0
0
Netherlands
Query!
State/province [70]
0
0
Rotterdam
Query!
Country [71]
0
0
Netherlands
Query!
State/province [71]
0
0
Utrecht
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Masovian
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Poznan
Query!
Country [74]
0
0
South Africa
Query!
State/province [74]
0
0
Cape Town
Query!
Country [75]
0
0
South Africa
Query!
State/province [75]
0
0
Pretoria
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Andalusia
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
A Coruña
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Barcelona
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Madrid
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Malaga
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Oviedo
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Pamplona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Valencia
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Zaragoza
Query!
Country [85]
0
0
Turkey
Query!
State/province [85]
0
0
Adana
Query!
Country [86]
0
0
Turkey
Query!
State/province [86]
0
0
Ankara
Query!
Country [87]
0
0
Turkey
Query!
State/province [87]
0
0
Antalya
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Bornova
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Istanbul
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
London
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Manchester
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
IO Biotech
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05155254
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Inge Marie Svane, MD, Prof
Query!
Address
0
0
Institut for Klinisk Medicin, Herlev-Gentofte Hospital; Denmark
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05155254
Download to PDF