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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04830124
Registration number
NCT04830124
Ethics application status
Date submitted
1/04/2021
Date registered
2/04/2021
Date last updated
20/03/2024
Titles & IDs
Public title
Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6
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Scientific title
A Phase 2, Open Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6
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Secondary ID [1]
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ALKS 4230-006
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Universal Trial Number (UTN)
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Trial acronym
ARTISTRY-6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma
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Mucosal Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Cancer
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Non melanoma skin cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nemvaleukin Alfa Subcutaneous
Treatment: Drugs - Nemvaleukin Alfa Intravenous
Treatment: Drugs - Nemvaleukin Alfa Intravenous Less Frequent Dosing
Experimental: Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1) - Patients with unresectable and/or metastatic cutaneous melanoma
Experimental: Advanced mucosal melanoma with IV Dosing (Cohort 2) - Patients with unresectable and/or metastatic mucosal melanoma
Experimental: Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3) - Patients with unresectable and/or metastatic cutaneous melanoma
Treatment: Drugs: Nemvaleukin Alfa Subcutaneous
Subcutaneous injection of nemvaleukin every 7 days
Treatment: Drugs: Nemvaleukin Alfa Intravenous
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
Treatment: Drugs: Nemvaleukin Alfa Intravenous Less Frequent Dosing
Intravenous (IV) infusion over 30 minutes once every 21 days or twice every 21 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Centrally-assessed overall response rate (ORR) (Cohort 1 and 2)
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Assessment method [1]
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ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug
Response will be based on RECIST v1.1 criteria
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Timepoint [1]
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Assessed up to 2 years from the first dose
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Primary outcome [2]
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Investigator-assessed overall response rate (ORR) (Cohort 3)
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Assessment method [2]
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ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug
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Timepoint [2]
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Assessed up to 2 years from the first dose
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Secondary outcome [1]
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Centrally-assessed duration of response (DOR) (Cohort 1 and 2)
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Assessment method [1]
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-DOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death
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Timepoint [1]
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Assessed up to 2 years from the first dose
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Secondary outcome [2]
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Centrally-assessed progression free survival (PFS) (Cohort 1 and 2)
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Assessment method [2]
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-PFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death
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Timepoint [2]
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Assessed up to 2 years from the first dose
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Secondary outcome [3]
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Centrally-assessed disease control rate (DCR) (Cohort 1 and 2)
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Assessment method [3]
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-DCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments
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Timepoint [3]
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Assessed up to 2 years from the first dose
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Secondary outcome [4]
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Centrally-assessed time to response (TTR) (Cohort 1 and 2)
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Assessment method [4]
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-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response
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Timepoint [4]
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Assessed up to 2 years from the first dose
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Secondary outcome [5]
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Incidence of treatment-emergent adverse events (All cohorts)
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Assessment method [5]
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Timepoint [5]
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Assessed up to 2 years from the first dose
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Secondary outcome [6]
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Investigator-assessed overall response rate (ORR) (Cohort 1 and 2)
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Assessment method [6]
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ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug
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Timepoint [6]
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Assessed up to 2 years from the first dose
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Secondary outcome [7]
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Investigator-assessed duration of response (DOR) (All cohorts)
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Assessment method [7]
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-DOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death
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Timepoint [7]
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Assessed up to 2 years from the first dose
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Secondary outcome [8]
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Investigator-assessed progression free survival (PFS) (All cohorts)
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Assessment method [8]
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-PFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death
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Timepoint [8]
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Up to 2 years from the first dose
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Secondary outcome [9]
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Investigator-assessed disease control rate (DCR) (All cohorts)
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Assessment method [9]
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-DCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments
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Timepoint [9]
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Assessed up to 2 years from the first dose
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Secondary outcome [10]
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Investigator-assessed time to response (TTR) (All cohorts)
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Assessment method [10]
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-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response
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Timepoint [10]
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Assessed up to 2 years from the first dose
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Secondary outcome [11]
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Investigator-assessed immune overall response rate (iORR) (All cohorts)
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Assessment method [11]
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-iORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug.
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Timepoint [11]
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Assessed up to 2 years from the first dose
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Secondary outcome [12]
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Investigator-assessed immune duration of response (iDOR) (All cohorts)
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Assessment method [12]
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-iDOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death
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Timepoint [12]
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Assessed up to 2 years from the first dose
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Secondary outcome [13]
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Investigator-assessed immune progression free survival (iPFS) (All cohorts)
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Assessment method [13]
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-iPFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death
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Timepoint [13]
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Assessed up to 2 years from the first dose
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Secondary outcome [14]
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Investigator-assessed immune disease control rate (iDCR) (All cohorts)
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Assessment method [14]
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-iDCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments
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Timepoint [14]
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Assessed up to 2 years from the first dose
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Secondary outcome [15]
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Investigator-assessed immune time to response (iTTR) (All cohorts)
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Assessment method [15]
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-iTTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete or partial response
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Timepoint [15]
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Assessed up to 2 years from the first dose
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Eligibility
Key inclusion criteria
- The patient must have the following tumor types:
Cohort 1: Patient has unresectable and/or metastatic cutaneous melanoma. No more than 5
patients with acral melanoma may enroll in this cohort.
Cohort 2: Patient has unresectable and/or metastatic mucosal melanoma.
Cohort 3: Patient has unresectable and/or metastatic cutaneous melanoma. Patients with
acral melanoma may not enroll in this cohort.
- The patient must have received previous treatment as follows:
1. Patient has received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy,
and no more than one other prior regimen of systemic anti-neoplastic therapy (eg,
targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy
counts as one prior regimen.
2. Patients have experienced objective response (partial response [PR] or CR; by
RECIST 1.1 or iRECIST) or stable disease (SD; by RECIST 1.1 or iRECIST) as best
overall response (BOR) to anti-PD-[L]1 therapy. Patients with confirmed
progressive disease (by RECIST 1.1 or iRECIST) as best response may be included,
if they received anti-PD-[L]1 therapy for a minimum of 12 weeks (eg, from first
dose to last dose).
3. Patients with BRAF mutations may or may not have received prior targeted therapy.
- Patients must have disease that is measurable based on RECIST 1.1., that has not
recently been irradiated or used to collect a biopsy.
- Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying
archival tumor tissue.
- Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an
estimated life expectancy of =3 months.
- Additional criteria may apply.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient has uveal melanoma (all cohorts) or acral melanoma (Cohort 2 and Cohort 3).
- Patient has received prior interleukin (IL)-2-based or IL-15-based cytokine therapy;
patient has had exposure, including intralesional, to IL-12 or analogs thereof.
- Patient requires systemic corticosteroids (>10 mg of prednisone daily, or equivalent)
however, replacement doses, topical, ophthalmologic, and inhalational steroids are
permitted.
- Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell
or bone marrow transplant.
- Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to
begin breastfeeding during the study period or within 30 days after last study drug
administration.
- Patients with active or symptomatic central nervous system metastases unless the
metastases have been treated by surgery and/or radiation therapy and/or gamma knife,
the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less
of corticosteroids for at least 2 weeks before the first dose, and the subject is
neurologically stable. Patients with leptomeningeal disease are excluded.
- Patient has known or suspected hypersensitivity to any components of nemvaleukin.
- Patients with an uncontrollable bleeding disorder.
- Patient has QT interval corrected by the Fridericia Correction Formula values of >470
msec (in females) or >450 msec (in males); patient who is known to have congenital
prolonged QT syndromes; or patient who is on medications known to cause prolonged QT
interval on ECG.
- Patient has developed Grade =3 immune-related AEs (irAEs) while on prior
immunotherapy, (eg, pneumonitis and nephritis) and has not recovered to =Grade 1
and/or are on systemic steroids within 14 days of first dose of study drug.
- Patients who have previously discontinued immunotherapy due to immune-related adverse
event (irAEs) will be excluded.
- Additional criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2025
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Actual
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Sample size
Target
176
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Mural Oncology Investigator Site - Waratah
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Recruitment hospital [2]
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Mural Oncology Investigator Site - Tugun
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Recruitment hospital [3]
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Mural Oncology Investigator Site - Woodville
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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4224 - Tugun
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Recruitment postcode(s) [3]
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5011 - Woodville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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Italy
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State/province [10]
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Milano
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Country [11]
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Italy
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State/province [11]
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Padova
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Country [12]
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Italy
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State/province [12]
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Perugia
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Country [13]
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Italy
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State/province [13]
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Siena
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Country [14]
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Korea, Republic of
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State/province [14]
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Seocho-gu
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul
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Country [16]
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Korea, Republic of
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State/province [16]
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Daegu
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Country [17]
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Korea, Republic of
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State/province [17]
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Daejeon
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Country [18]
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Spain
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State/province [18]
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Barcelona
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Spain
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Madrid
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Country [20]
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Spain
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State/province [20]
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Málaga
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Spain
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State/province [21]
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Zaragoza
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Country [22]
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Taiwan
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State/province [22]
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Kaohsiung
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Taiwan
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State/province [23]
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Taipei
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Country [24]
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Taiwan
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State/province [24]
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Taoyuan
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United Kingdom
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State/province [25]
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London
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Country [26]
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United Kingdom
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State/province [26]
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Manchester
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Country [27]
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United Kingdom
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State/province [27]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Mural Oncology, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in
patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04830124
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carlos Mayo, MD
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Address
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Mural Oncology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Senior Director, Global Clinical Services
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Address
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Country
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Phone
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888-235-8008 (US Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04830124
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