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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03798626
Registration number
NCT03798626
Ethics application status
Date submitted
7/01/2019
Date registered
10/01/2019
Date last updated
18/06/2024
Titles & IDs
Public title
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
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Scientific title
Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma
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Secondary ID [1]
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2018-003952-19
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Secondary ID [2]
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CVPM087A2101
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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:
Colorectal Cancer
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Gastroesophageal Cancer
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Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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0
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Cancer
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Gevokizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Modified FOLFOX6
Treatment: Drugs - FOLFIRI
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Cabozantinib
Experimental: Cohort A: 1st line colorectal cancer - Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab
Experimental: Cohort B: 2nd line colorectal cancer - Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab
Experimental: Cohort C: 2nd line gastroesophageal cancer - Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab
Experimental: Cohort D: 2nd or 3rd line renal cell carcinoma - Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib
Treatment: Drugs: Gevokizumab
60 mg/mL concentration; administered intravenously (IV)
Treatment: Drugs: Bevacizumab
25 mg/mL concentration; administered IV
Treatment: Drugs: Modified FOLFOX6
Oxaliplatin \[5 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]
Treatment: Drugs: FOLFIRI
Irinotecan \[20 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\]
Treatment: Drugs: Ramucirumab
10 mg/mL concentration; administered IV
Treatment: Drugs: Paclitaxel
6 mg/mL concentration; administered IV
Treatment: Drugs: Cabozantinib
60 mg tablet; administered orally
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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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Part 1a (Dose finding): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy
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Assessment method [1]
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Log scale change of hs-CRP at Day 15 from baseline
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Timepoint [1]
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Baseline, Day 15
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Primary outcome [2]
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Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D]
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Assessment method [2]
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DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
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Timepoint [2]
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First 4 weeks of combination treatment
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Primary outcome [3]
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Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B]
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Assessment method [3]
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DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
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Timepoint [3]
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First 6 weeks of combination treatment
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Primary outcome [4]
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Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level]
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Assessment method [4]
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PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
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Timepoint [4]
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At 15 months
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Primary outcome [5]
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Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level]
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Assessment method [5]
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PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
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Timepoint [5]
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At 9 months
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Primary outcome [6]
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Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level]
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Assessment method [6]
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PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
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Timepoint [6]
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At 6 months
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Secondary outcome [1]
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Overall response rate (ORR) per investigator assessment using RECIST v1.1
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Assessment method [1]
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ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Duration of response (DOR) per investigator assessment using RECIST v1.1
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Assessment method [2]
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Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Disease Control Rate (DCR) per investigator assessment using RECIST v1.1
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Assessment method [3]
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DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD), according to RECIST 1.1.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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OS is defined as the time from date of first dose of study treatment to date of death due to any cause.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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PFS by baseline hs-CRP category using RECIST 1.1 [Cohort A and B at RDE level]
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Assessment method [5]
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PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause.
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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PFS for subjects from Part 1b at doses other than RDE level (Cohort A and Cohort B)
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Assessment method [6]
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PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Serum concentration of gevokizumab, as monotherapy and in the combination regimens
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Assessment method [7]
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To characterize the pharmacokinetics of gevokizumab therapy
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Serum concentration of bevacizumab
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Assessment method [8]
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To characterize the pharmacokinetics of bevacizumab therapy
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Serum concentration of ramucirumab
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Assessment method [9]
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To characterize the pharmacokinetics of ramucirumab therapy
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Serum concentration of irinotecan
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Assessment method [10]
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To characterize the pharmacokinetics of irinotecan therapy
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Timepoint [10]
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Up to 3 months
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Secondary outcome [11]
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Serum concentration of paclitaxel
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Assessment method [11]
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To characterize the pharmacokinetics of paclitaxel therapy
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Timepoint [11]
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Up to 3 months
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Secondary outcome [12]
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Serum concentration of cabozantinib
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Assessment method [12]
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To characterize the pharmacokinetics of cabozantinib therapy
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Timepoint [12]
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Up to 3 months
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Secondary outcome [13]
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Number of patients with anti-drug antibodies for gevokizumab in the combination regimens
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Assessment method [13]
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Incidence of immunogenicity for gevokizumab
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Timepoint [13]
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Up to 5 years
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Secondary outcome [14]
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Number of patients with anti-drug antibodies for bevacizumab in the combination regimens
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Assessment method [14]
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Incidence of immunogenicity for bevacizumab
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Timepoint [14]
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Up to 5 years
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Secondary outcome [15]
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Number of patients with anti-drug antibodies for ramucirumab in the combination regimens
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Assessment method [15]
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Incidence of immunogenicity for ramucirumab
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Timepoint [15]
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Up to 5 years
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Eligibility
Key inclusion criteria
* Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
* Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
For Cohort A:
- First line metastatic colorectal cancer.
For Cohort B:
- Second line metastatic colorectal cancer that has progressed on prior chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
For Cohort C:
- Second line metastatic gastroesophageal cancer that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.
For Cohort D:
- Second or third line metastatic renal cell carcinoma with a clear-cell component and has received one or two lines of treatment for metastatic disease that included an anti-angiogenic agent for at least 4 weeks with radiologic progression on that treatment.
For subjects starting from Part 1a in Cohorts A and B:
* Serum hs-CRP at screening = 10 mg/L.
* Not requiring immediate initiation of anti-cancer therapy per investigator's best judgement.
For subjects starting from Part 2 in Cohort C:
- Serum hs-CRP at screening = 10 mg/L.
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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
For All Cohorts:
* Currently receiving any of the prohibited medications or has contraindications as outlined in the protocol.
* Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
* Suspected or proven immunocompromised state, or infections (as defined in the protocol).
* Conditions that have a high risk of clinically significant bleeding after administration of anti-VEGF agents.
* Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
For Cohort D:
* Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
* Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.
Other protocol-defined inclusion/exclusion 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
22/05/2019
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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
30/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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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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0
United States of America
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State/province [2]
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Missouri
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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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Tennessee
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Country [4]
0
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Belgium
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State/province [4]
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Antwerpen
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Country [5]
0
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Belgium
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State/province [5]
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Bruxelles
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0
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Belgium
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State/province [6]
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Leuven
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Canada
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State/province [7]
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Alberta
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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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Chile
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State/province [9]
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Santiago
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Country [10]
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Czechia
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State/province [10]
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Czech Republic
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Country [11]
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Germany
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State/province [11]
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Dresden
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Country [12]
0
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Germany
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State/province [12]
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Frankfurt
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Country [13]
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Germany
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State/province [13]
0
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Ulm
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Country [14]
0
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Israel
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State/province [14]
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Ramat Gan
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Country [15]
0
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Israel
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State/province [15]
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Tel Aviv
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Country [16]
0
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Italy
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State/province [16]
0
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MI
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Country [17]
0
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Japan
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State/province [17]
0
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Aichi
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Country [18]
0
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Japan
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State/province [18]
0
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Chiba
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Country [19]
0
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Japan
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State/province [19]
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Osaka
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Country [20]
0
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Japan
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State/province [20]
0
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Shizuoka
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0
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Japan
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State/province [21]
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Tokyo
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Korea, Republic of
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Seoul
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Singapore
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Singapore
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0
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Spain
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State/province [24]
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Andalucia
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0
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Spain
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State/province [25]
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Catalunya
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Country [26]
0
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Spain
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State/province [26]
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Comunidad Valenciana
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Country [27]
0
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Spain
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State/province [27]
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Madrid
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Country [28]
0
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Taiwan
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State/province [28]
0
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Tainan
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Country [29]
0
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United Kingdom
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State/province [29]
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London
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Country [30]
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United Kingdom
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State/province [30]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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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 will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
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Trial website
https://clinicaltrials.gov/study/NCT03798626
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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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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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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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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT03798626
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