- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721301
Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer the LUMINESCENCE Trial
October 16, 2023 updated by: Niels Halama, University Hospital Heidelberg
LUMINESCENCE-001 Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer
The study will be conducted in compliance with Good Clinical Practices (ICH-GCP) and the Declaration of Helsinki, and in accordance with applicable legal and regulatory requirements, including archiving of essential documents.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A study to evaluate the safety, tolerability and feasibility of treatment with Maraviroc, nivolumab and ipilimumab in layers of colon and pancreatic cancer patients
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Heidelberg, Germany, 69120
- University of Heidelberg / NCT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- written informed consent given, signed and dated
- age ≥ 18 years
- male or female patient with a history of treated metastatic stage IV colorectal or pancreatic cancer with liver metastases of the primary colorectal or pancreatic cancer
- histologically confirmed primary colorectal or pancreatic cancer
- preferentially with metastatic lesion in the liver amenable to biopsy (must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST criteria measured within 56 days prior to trial inclusion)
- expected survival of at least three months
- Karnofsky performance status > 70 %
- patients that have received current standard treatment options (or could not receive treatment due to medical reasons, e.g. allergic reactions, contraindications, toxicities etc.) for colorectal cancer (oxaliplatin or irinotecan in combination or alone with 5-FU with or without treatment combinations of cetuximab and/or bevacizumab or panitumumab, trifluridine plus tipiracil) or patients with pancreatic cancer that have received standard treatment options (at least first line therapy, progression or intolerance to oxaliplatin, irinotecan and 5-FU, FOLFIRINOX as first or second line therapy) or platinum containing adjuvant chemotherapy and palliative after first line chemotherapy
- no chemotherapy treatment within the last two weeks (to baseline)
- within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:
Laboratory Parameter Range Absolute neutrophil count (ANC) ≥ 1000/mm3 (≥ 1.0 x 109/L) Platelets ≥ 50.000/mm3 (≥ 80 x 109/L) Creatinine Clearance limit as assessed by GFR > 360 mL/min/1.73m² ALT and AST < 3.0 x ULN (w. liver met.) total bilirubin hemoglobin < 1.5 x ULN >9 g/dl
- ability to understand character and individual consequences of the clinical trial
- if the patient is female, she must be of non-childbearing potential, or practice highly effective contraception (Pearl Index <1%, e.g. intrauterine device (IUD)) while receiving study drug and up to 5 months from the last dose of study drug.
- if the patient is male, he must continue contraception for at least 31 weeks (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male patients must abstain from sperm donation during this time
Exclusion Criteria:
Patients presenting with any of the following criteria will not be included in the trial:
- Patients with severe kidney disorders (GFR of <30 mL/min/1.73m² and diagnosed kidney disease) or who are on hemodialysis.
- The patient requires concomitant chronic treatment with systemic corticosteroids or any other systemic immunosuppressive agents. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease (See also Section 7.7)
- Patients taking immunomodulatory medication (e.g. Type 1 interferons).
- Current use of any investigational or non-registered product (drug or vaccine) other than the study treatment
- Patients with a single metastatic lesion without identified concomitant lymph node metastasis (i.e. a patient with the intent to resect the metastasis)
- Patients with metastatic colorectal or pancreatic cancer that have a drastic clinical progression (e.g. from Karnofsky performance 100% to 70%) within the last six weeks before screening cannot participate
- The patient with active autoimmune disease or with a history of autoimmune disease.
- The patient has a family history of congenital or hereditary immunodeficiency.
- The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
- The patient has concurrent chronic severe medical problems (significant heart failure, uncontrolled diabetes, bleeding disorder, interstitial lung disease, etc.), unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
- Patients with untreated known CNS metastases, patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to trial participation.
- The patient has previous or concomitant malignancies at other sites, except effectively treated carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- For female patients: the patient is pregnant or lactating.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- Known allergy or hypersensitivity to peanuts, soy, soy beans or derivatives of soy or peanuts
- Contra-indication for MRI
- Participation in another clinical trial within three weeks before screening day
- Patient will not be allowed to enroll in this trial more than once.
- Known microsatellite-instability (MSI-H or dMMR) as evidenced by a standard laboratory practice (e.g. PCR or staining or sequencing etc.)
- Prisoners or patients who are involuntarily incarcerated.
- Patients who are compulsorily detained for treatment of either a psychiatric or physical(e.g., infectious disease) illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Combination immunotherapy
Treatment arm with Nivolumab, Ipilimumab and Maraviroc combination treatment
|
In the single treatment arm, all patients receive Nivolumab, Ipilimumab and Maraviroc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants and severity of treatment-related adverse Events as assessed by CTCAE v4.0
Time Frame: up to 11 days
|
Safety and tolerability of combined Maraviroc, Ipilimumab and Nivolumab
|
up to 11 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: up to 36 months
|
Progression free survival after initiation of trial medication, time to progression on trial medication, radiologic evaluation based on RECIST and iRECIST criteria
|
up to 36 months
|
Overall Survival
Time Frame: up to 36 months
|
Overall survival after initiation of trial medication, radiologic evaluation based on RECIST and iRECIST criteria
|
up to 36 months
|
Tissue Response
Time Frame: up to 3 months
|
Detailed evaluation of in-treatment biopsy compared to pre-treatment biopsies, investigating overt tumor cell death, immune cell activation, immune cell density and general markers of proliferation
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2017
Primary Completion (Actual)
March 15, 2023
Study Completion (Actual)
March 15, 2023
Study Registration Dates
First Submitted
November 12, 2020
First Submitted That Met QC Criteria
January 20, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 16, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- HIV Fusion Inhibitors
- Viral Fusion Protein Inhibitors
- CCR5 Receptor Antagonists
- Nivolumab
- Maraviroc
- Ipilimumab
Other Study ID Numbers
- 2017-003297-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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