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Colorectal Cancer MetastaticPhase 1NCT04721301

Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer the LUMINESCENCE Trial

A Phase 1 study testing Nivolumab plus Ipilimumab plus Maraviroc in people with Colorectal Cancer Metastatic and Pancreatic Cancer Metastatic, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab plus Ipilimumab plus Maraviroc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
15 Jan 2017to 15 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Heidelberg / NCT

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: 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.

Read the 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

Being tested
Nivolumab plus Ipilimumab plus Maraviroc
Keywords
microsatellite stable, immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab plus Ipilimumab plus MaravirocCombination product

    In the single treatment arm, all patients receive Nivolumab, Ipilimumab and Maraviroc

Study groups in NCT04721301
Study groupRoleWhat they receive
Combination immunotherapyExperimentalTreatment arm with Nivolumab, Ipilimumab and Maraviroc combination treatment
Receives: Combination Product: Nivolumab plus Ipilimumab plus Maraviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants and severity of treatment-related adverse Events as assessed by CTCAE v4.0

    Safety and tolerability of combined Maraviroc, Ipilimumab and Nivolumab

    Measured: up to 11 days

Secondary outcomes (3)

  1. Progression Free Survival

    Progression free survival after initiation of trial medication, time to progression on trial medication, radiologic evaluation based on RECIST and iRECIST criteria

    Measured: up to 36 months

  2. Overall Survival

    Overall survival after initiation of trial medication, radiologic evaluation based on RECIST and iRECIST criteria

    Measured: up to 36 months

  3. Tissue Response

    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

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start15 Jan 2017
  3. Primary completion15 Mar 2023
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Center Phase 1 trial
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04721301
Sponsor's protocol ID
2017-003297-13
Other IDs
2017
Status last verified
Oct 2023
First submitted
12 Nov 2020
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab plus Ipilimumab plus Maraviroc in people with Colorectal Cancer Metastatic and Pancreatic Cancer Metastatic, run by University Hospital Heidelberg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants and severity of treatment-related adverse Events as assessed by CTCAE v4.0 (time frame: up to 11 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04721301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

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