Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) (MERECA)
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| ClinicalTrials.gov Identifier: NCT02432846 |
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Recruitment Status :
Completed
First Posted : May 4, 2015
Last Update Posted : June 22, 2021
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Sponsor:
Immunicum AB
Collaborators:
TFS Trial Form Support
Accelovance
Information provided by (Responsible Party):
Immunicum AB
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Brief Summary:
The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Cell Carcinoma, Metastatic | Biological: Intuvax (INN: ilixadencel) Drug: Sunitinib | Phase 2 |
Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone.
Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly.
All patients will start Sunitinib treatment 5-8 weeks after operation.
Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum AB to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients |
| Study Start Date : | April 2015 |
| Actual Primary Completion Date : | January 31, 2021 |
| Actual Study Completion Date : | January 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Vaccines
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intuvax (INN: ilixadencel)+ Nephrectomy+Sunitinib
Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).
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Biological: Intuvax (INN: ilixadencel)
Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.
Other Name: COMBIG-DC Drug: Sunitinib Cytostatic/cytotoxic drug: protein kinase inhibitor .
Other Name: Sutent |
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Active Comparator: Nephrectomy+Sunitinib
Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).
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Drug: Sunitinib
Cytostatic/cytotoxic drug: protein kinase inhibitor .
Other Name: Sutent |
Primary Outcome Measures :
- Overall survival (OS) from randomization overall in mRCC patients and by each subgroup i.e. in high-risk and in intermediate risk mRCC patients. [ Time Frame: up to 5 years after end of study ]
- 18 months survival rate from randomization overall in mRCC patients and by each subgroup i.e. in high risk and intermediate risk mRCC patients. [ Time Frame: up to 18 months ]
Secondary Outcome Measures :
- Frequency and proportion of AEs including clinical significant changes in laboratory tests and vital signs from screening. [ Time Frame: up to 18 months ]
- Progression free survival (PFS) from start of Sunitinib according to RECIST 1.1. [ Time Frame: up to 18 months ]
- Proportion of objective response rate (ORR) from start of sunitinib treatment and duration of response in each subgroup. [ Time Frame: up to 18 months ]
- Time to progression (TTP) from start of sunitinib treatment [ Time Frame: up to 18 months ]
- Relative number of tumor infiltrating CD8+ TCells in the resected primary tumor compared to related number of infiltrating CD8+ TCells in available diagnostic pre-biopsy (sample from either primary tumor or metastasis acceptable) [ Time Frame: 2 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Newly (<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ≥10mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology
- Planned resection of primary tumor
- Primary tumor diameter ≥40 mm
- Candidate for first-line therapy with sunitinib initiated 5-8 weeks after nephrectomy
- Female or male ≥18 years of age
- Willing and able to provide informed consent
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Adequate hematological parameters, i.e:
- B-Leukocyte count ≥4.5 x10e9/L
- B-Platelet count ≥150 x10e9/L
- B-Hemoglobin ≥90 g/L
- S-creatinine and S-bilirubin ≤ 1.5 x ULN. S-ALAT and S-ASAT ≤ 2.5 x ULN (or ≤5 in case of liver metastases)
- Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) Female of childbearing potential must have a negative from Screening until 90 days after last dose of INTUVAX and/or until completed sunitinib treatment whichever occurs later.blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating.
or Male agreeing to use condoms from Screening until 90 days after last dose of INTUVAX and/or until completed sunitinib treatment whichever occurs later, or male having a female partner who is using a highly efficient method of contraception as described above.
Exclusion Criteria:
- Life expectancy less than 4 months
- CNS metastasis that is symptomatic or progressing or untretaed or that required current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
- Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
- Treatment with per oral systemic corticosteroids exceeding 10mg/day within seven (7) days before Screening until nephrectomy (inhaled, intranasal and local steroids accepted irrespective of dose)
- Known cardiomyopathy and/or clinical significant abnormal ECG findings at Screening disqualifying the patient from nephrectomy and from subsequent sunitinib treatment
- Karnofsky performance status <70%
- National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Clinically significant gastrointestinal abnormalities
- Uncontrolled hypertension, or uncontrolled diabetes mellitus
- Pulmonary embolism within 12 months before screening
- Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer
- Ongoing infection that requires parenteral treatment with antibiotics
- Active or latent virus disease (HIV, hepatitis B and hepatitis C)
- ECOG performance status >2 after optimization of analgesics
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Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.:
- Prothrombin Time - International Normalized Ratio (PT-INR)
- Activated Partial Thromboplastin Time (APTT) patients being treated with anticoagulants are excluded if the coagulation parameters are outside the therapeutic intervals as described in the SmPC/USPI for the administered treatment
- Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- Known hypersensitivity or allergy sunitinib or to chemically related products or likely to be exacerbated to by any component of the study products
- Prior systemic antitumour therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumour is allowed
- Exposure to other investigational products within 28 days prior to Screening Visit
- patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the investigator and or per local standard of care) during vaccination and nephrectomy, is not an option
- History of alcohol or substance abuse
- Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432846
Locations
Show 28 study locations
Sponsors and Collaborators
Immunicum AB
TFS Trial Form Support
Accelovance
Investigators
| Principal Investigator: | Börje Ljungberg, MD, Prof | Umeå University Hospital |
| Responsible Party: | Immunicum AB |
| ClinicalTrials.gov Identifier: | NCT02432846 |
| Other Study ID Numbers: |
IM-201 2014-004510-28 ( EudraCT Number ) |
| First Posted: | May 4, 2015 Key Record Dates |
| Last Update Posted: | June 22, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |