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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/NCT02554812
Registration number
NCT02554812
Ethics application status
Date submitted
16/09/2015
Date registered
18/09/2015
Date last updated
23/06/2023
Titles & IDs
Public title
A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
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Scientific title
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES
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Secondary ID [1]
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2015-002552-27
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Secondary ID [2]
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B9991004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Avelumab
Treatment: Drugs - Utomilumab
Treatment: Drugs - PF-04518600
Treatment: Drugs - PD 0360324
Treatment: Drugs - CMP-001
Experimental: Cohort A1 - NSCLC patients treated with avelumab + utomilumab (Dose level 1)
Experimental: Cohort A2 - NSCLC patients treated with avelumab + utomilumab (Dose level 2)
Experimental: Cohort A3 - NSCLC patients treated with avelumab + utomilumab (Dose level 3)
Experimental: Cohort A4 - Melanoma patients treated with avelumab +utomilumab
Experimental: Cohort A5 - SCCHN patients treated with avelumab + utomilumab
Experimental: Cohort A6 - TNBC patients treated with avelumab + utomilumab
Experimental: Cohort A7 - SCLC that has progressed after at least 1 line of platinum-containing therapy treated with avelumab +utomilumab
Experimental: Cohort A8 - NSCLC first-line Stage IV treated with avelumab +PF-05082566
Experimental: Combination B Dose Escalation - PF-04518600 + avelumab in selected tumor types
Experimental: Combination B Expansion Cohorts - PF-04518600 + avelumab in selected tumor types
Experimental: Combination C Dose escalation cohorts - PD 0360324 + avelumab in selected tumor types
Experimental: Combination C Dose expansion cohorts - PD 0360324 + aveluamb in selected tumor types
Experimental: Combination D Dose escalation cohorts - PF-05082566 + PF-04518600 + avelumab in selected tumor types
Experimental: Combination D Dose expansion cohorts - PF-05082566 + PF-04518600 + avelumab in selected tumor types
Experimental: Cohort A9 - NSCLC first-line Stage IV treated with avelumab +utomilumab (sequential starting with utomilumab monotherapy followed by combination)
Experimental: Cohort A10 - NSCLC first-line Stage IV treated with avelumab + utomilumab (sequential starting with avelumab monotherapy followed by combination)
Experimental: Cohort F1 - CMP-001 +avelumab in SCCHN
Experimental: Cohort F2 - CMP-001+avelumab+utomilumab in SCCHN
Experimental: Cohort F3 - CMP-001 +avelumab+PF-04518600 in SCCHN
Treatment: Drugs: Avelumab
Anti-PD-L1 antibody
Treatment: Drugs: Utomilumab
Anti-4-1BB antibody
Treatment: Drugs: PF-04518600
OX40 Agonist
Treatment: Drugs: PD 0360324
Anti-M-CSF
Treatment: Drugs: CMP-001
TLR9 agonist
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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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Number of participants with Dose-Limiting Toxicities (DLT)
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Assessment method [1]
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For Phase 1b: DLTs for Combination A (avelumab and PF-05082566) or Combination B (avelumab and PF-04518600) or Combination C (avelumab and PD 0360324) or Combination D (Avelumab and utomilumab and PF-04518600)occurring during the first 8 weeks of treatment (first 2 cycles). For Phase 1b: DLT for Combination F (avelumab plus CMP-001 and utomilumab or PF-04518600) occurring during the first 4 weeks of treatment (first cycle).
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Timepoint [1]
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First 8 weeks of treatment (Combination A-D) First 4 weeks of treatment (CombinationF)
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Primary outcome [2]
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Objective Response - Number of Participants With Objective Response
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Assessment method [2]
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For Phase 2: Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1).
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Timepoint [2]
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Baseline up to approximately 24 months
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Secondary outcome [1]
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Cmax of avelumab (MSB0010718C)
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Assessment method [1]
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Cmax defined as the maximum plasma concentration of avelumab (MSB0010718C)
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Timepoint [1]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10
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Secondary outcome [2]
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Cmax of PF-05082566
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Assessment method [2]
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Cmax defined as the maximum plasma concentration of PF-05082566
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Timepoint [2]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, and then on Day 1 of Cycles 3, 5, 8, and 12
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Secondary outcome [3]
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Ctrough of avelumab (MSB0010718C)
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Assessment method [3]
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Ctrough is defined as the trough plasma concentration at the end of an avelumab dosage interval.
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Timepoint [3]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10
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Secondary outcome [4]
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Ctrough of PF-05082566
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Assessment method [4]
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Ctrough is defined as the trough plasma concentration at the end of a PF-05082566 dosage interval.
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Timepoint [4]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, and then on Day 1 of Cycles 3, 5, 8, and 12
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Secondary outcome [5]
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Anti-Drug Antibody (ADA) levels of avelumab (MSB0010718C)
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Assessment method [5]
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Immunogenicity assessment of avelumab (MSB0010718C).
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Timepoint [5]
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Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 10
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Secondary outcome [6]
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Anti-Drug Antibody (ADA) levels of PF-05082566
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Assessment method [6]
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Immunogenicity assessment of PF-05082566.
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Timepoint [6]
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Pre-dose on Day 1 of Cycles 1, 3, 5, 8, and 12
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Secondary outcome [7]
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Time to Tumor Response (TTR)
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Assessment method [7]
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Time to Tumor Response (TTR) is defined for patients with confirmed objective response (CR or PR) as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the first documentation of objective tumor response.
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Timepoint [7]
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Baseline up to approximately 24 months
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Secondary outcome [8]
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Duration of Response (DR)
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Assessment method [8]
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Duration of Response (DR) is defined for patients with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
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Timepoint [8]
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Baseline up to approximately 24 months
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Secondary outcome [9]
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Progression-Free Survival (PFS)
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Assessment method [9]
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Progression-Free Survival (PFS) is defined as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurs first.
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Timepoint [9]
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Baseline up to approximately 24 months
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Secondary outcome [10]
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Overall Survival (OS)
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Assessment method [10]
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Overall Survival (OS) is defined as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the date of death.
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Timepoint [10]
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Baseline up to approximately 24 months
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Secondary outcome [11]
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Tumor tissue biomarkers
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Assessment method [11]
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Tumor tissue biomarkers, including, but not limited to, PD-L1 expression and tumor infiltrating CD8+ T lymphocytes
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Timepoint [11]
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Baseline
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Secondary outcome [12]
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Cmax of PF-04518600
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Assessment method [12]
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Cmax defined as the maximum plasma concentration of PF-04518600
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Timepoint [12]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10
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Secondary outcome [13]
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Anti-Drug Antibody (ADA) levels of PF-04518600
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Assessment method [13]
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Immunogenicity assessment of PF-04518600.
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Timepoint [13]
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Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 10
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Secondary outcome [14]
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Ctrough of PF-04518600
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Assessment method [14]
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Ctrough is defined as the trough plasma concentration at the end of a PF-04518600 dosage interval.
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Timepoint [14]
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Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10
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Eligibility
Key inclusion criteria
- Histological or cytological diagnosis of advanced/metastatic solid tumor. Measurable
disease by RECIST 1.1 with at least 1 measurable lesion that has not been previously
irradiated. Availability of tumor specimen taken within 1 year prior to study entry,
with no intervening systemic anti-cancer therapy. No prior PD-1/PDL-1 therapy allowed.
Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy
or for which no standard therapy is available, and Phase 2, patients with NSCLC,
melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. 1st line NSCLC
must demonstrate to express PD-L1. Activating EGFR mutation, ALK, ROS1
translocation/rearrangements are not permitted. Combination B: Phase 1b, patients with
advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard
therapy or for which no standard therapy is available, and Phase 2, patients with
NSCLC, melanoma, or SCCHN. Up to 2 lines of prior therapy in advanced/metastatic
disease setting allowed. Activating EGFR mutation, ALK, ROS1
translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN,
NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to 2 lines of prior
therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either
inoperable or requires extensive resection. Prior treatment with agents targeting
CSF-1/CSF-1R not allowed. NSCLC activating EGFR mutation, ALK, ROS1
translocation/rearrangements are not permitted. Combination D: NSCLC, melanoma, SCCHN,
bladder cancer. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements
are not permitted. Up to 2 lines of prior therapy in advanced/metastatic disease
setting allowed. Combination F: Recurrent or metastatic SCCHN. One to three prior
lines of systemic therapy for advanced stage or metastatic disease. Patients must have
received anti PD-1/PD-L1 containing therapy (requires at least two doses of PD-1/PD-L1
agent).Disease progression no earlier than 6 weeks from initiation of the latest
anticancer therapy. Evidence of radiologic progression is required. • Patient must be
a candidate for intralesional administration with at least one tumor lesion which can
be injected safely.
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 3 months
- Adequate bone marrow, renal, and liver function
- Resolved acute effects of prior therapy
- Negative serum pregnancy test at screening
- Male and female patients able to have children must agree to use at least 1 highly
effective method of contraception throughout the study and for at least 90 days after
last dose
- Signed and dated informed consent
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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
- Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or
small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14
days prior to study entry. Combination F:PD-1/PD-L1 agent within 14 days prior study
entry.
- Current or prior use of immunosuppressive medication within 7 days prior to study
entry
- Active autoimmune disease requiring systemic steroids or immunosuppressive agents
within 7 days prior to study entry
- Known prior or suspected hypersensitivity to investigational products
- Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry
- Patients with known symptomatic brain metastases requiring steroids
- Previous high-dose chemotherapy requiring stem cell rescue
- Prior allogeneic stem cell transplant or organ graft
- Any of the following within 6 months prior to study entry: myocardial infarction,
uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive
heart failure, cerebrovascular accident, or transient ischemic attack
- Symptomatic pulmonary embolism within 6 months prior to study entry
- Known HIV or AIDS-related illness
- Active infection requiring systemic therapy
- Positive HBV or HCV test indicating acute or chronic infection
- Administration of a live vaccine within 4 weeks prior to study entry
- Diagnosis of other malignancy within 5 years, except for adequately treated basal cell
or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or
low-grade (Gleason =6) prostate cancer
- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study entry and/or during study participation
- Persisting toxicity related to prior therapy >Grade 1
- Other severe acute or chronic medical condition
- Combo C :Existing periorbital edema.
- Combo C : Hypocalcemia, clinically significant bone disease or recent bone fracture
(within 12 weeks prior study entry)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
9/11/2015
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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
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Actual
23/03/2023
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Sample size
Target
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Accrual to date
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Final
409
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Macquarie University - Macquarie University
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [4]
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The Mater Hospital - North Sydney
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Recruitment hospital [5]
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Baxter Healthcare - Old Toongabie
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Recruitment hospital [6]
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Brighton Medical Imaging - Brighton
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Recruitment hospital [7]
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Cabrini Hospital Brighton - Brighton
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Recruitment hospital [8]
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Austin Health - Heidelberg
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [10]
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Cabrini Hospital - Malvern
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Recruitment hospital [11]
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Malvern Medical Imaging - Malvern
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Recruitment hospital [12]
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Macquarie Heart - New South Wales
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2109 - Macquarie University
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Recruitment postcode(s) [3]
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2060 - North Sydney
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Recruitment postcode(s) [4]
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2146 - Old Toongabie
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Recruitment postcode(s) [5]
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3186 - Brighton
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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2109 - New South Wales
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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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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Iowa
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United States of America
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Michigan
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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State/province [8]
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Pennsylvania
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United States of America
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Rhode Island
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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Cedex
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France
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Villejuif
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Japan
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Chiba
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Japan
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Tokyo
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Poland
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Mazowieckie
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Poland
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Warszawa
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Taiwan
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Taipei
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics,
pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination
with other cancer immunotherapies in patients with locally advanced or metastatic solid
tumors. The primary purpose is to assess the safety and early signs of efficacy of various
avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as
appropriate, in a limited series of indications.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02554812
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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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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02554812
Download to PDF