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Advanced Renal Cell CarcinomaPhase 2NCT04203901

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

A Phase 2 study testing CMN-001, Nivolumab+Ipilimumab and Lenvatinib+Everolimus in people with Advanced Renal Cell Carcinoma, run by CoImmune at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic cells, which have been co-electroporated with both in vitro transcribed (IVT) RNA from an autologous tumor specimen and CD40L RNA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
CMN-001, Nivolumab+Ipilimumab and Lenvatinib+Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
9 sitesUnited States
Study dates
22 Jul 2020to 28 Sep 2023
Phase
Phase 2
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

  • Age ≥ 18 years
  • Advanced disease histologically assessed as RCC, with predominantly clear cell histology
  • Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of study participation per iRECIST
  • Subjects who are candidates for standard first-line therapy
  • Time from initial RCC diagnosis to initiation of systemic treatment (Nivolumab+Ipilimumab) of <1 year
  • Karnofsky Performance Status (KPS) ≥ 70%
Show all 25Show fewer
  • Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
  • Adequate hematologic function, as defined by central laboratory values for all three of the following criteria:
  • Absolute neutrophil count (ANC) LLN, and
  • Platelets 75,000/mm3 or 75.0 x 109/L, and
  • Hemoglobin (Hgb) 8.0 g/dL
  • Adequate renal function, as defined by either of the following criteria:
  • Serum creatinine 1.5 x upper limit of normal (ULN),
  • OR, if serum creatinine greater than 1.5 x ULN, estimated glomerular filtration rate (eGFR) 30 mL/min
  • Adequate hepatic function, as defined by both of the following:
  • Total serum bilirubin 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN or, AST and ALT 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Adequate coagulation function as defined by either of the following criteria:
  • INR < 1.5 x ULN
  • For subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these patients may exceed 1.5 x ULN if that is the goal of anticoagulant therapy.
  • Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
  • Normal ECG or clinically non-significant finding(s) at Screening, in the Investigator's opinion
  • Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Who cannot join

  • Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA.
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
  • Patients will be excluded if they have <2 of the following risk factors at Screening:
  • Time from diagnosis to systemic treatment < 1 year
  • Hgb < LLN
  • Corrected calcium > 10.0 mg/dL
Show all 36Show fewer
  • KPS < 80%
  • Neutrophils > ULN
  • Platelets > ULN
  • NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Week 0)
  • Clinically significant cardiovascular conditions within 3 months prior to Randomization, which in the Investigator's opinion prohibits the initiation of standard targeted therapy, initiating with sunitinib, including:
  • Cardiac angioplasty
  • Myocardial infarction
  • Unstable angina
  • Coronary artery by-pass graft or stenting
  • Class III or IV congestive heart failure (CHF), per NYHA Classification NOTE: Patients with left ventricular ejection fraction (LVEF) < LLN as assessed by either echocardiography or multiple gated acquisition (MUGA) scan, who are asymptomatic and are NOT classified as having NYHA Class III or IV CHF, may be eligible but should be monitored for LVEF changes while on sunitinib therapy as recommended in the current sunitinib prescribing information.
  • Symptomatic peripheral vascular disease
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • Symptomatic or uncontrolled pulmonary embolism or deep vein thrombosis (DVT)
  • Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, or prolongation of the QTc for males > 450 msec and for females > 470 msec as corrected by either the Fridericia or Bazett formula
  • Uncontrolled or untreated atrial fibrillation
  • Poorly controlled hypertension, defined as a systolic blood pressure (SBP), ≥ 150 mm Hg or diastolic blood pressure (DBP) ≥ 90 mm Hg NOTE: Initiation of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on 2 occasions separated by at least 1 hour. Mean SBP/DBP values must be less than 150/90 for eligibility.
  • Evidence of active bleeding or a bleeding diathesis at Screening
  • Significant gastrointestinal abnormalities:
  • Any history of major resection of the stomach or small bowel with ongoing impaired healing.
  • Malabsorption syndrome with active symptoms in the Investigator's opinion, within 3 months prior to Randomization
  • Active peptic ulcer, which cannot be appropriately managed in the Investigator's opinion, within 3 months prior to Randomization
  • Intra-luminal bleeding lesions within 3 months prior to Randomization
  • History of abdominal fistula or intra-abdominal abscess within 3 months prior to Randomization
  • Pre-existing thyroid abnormality with thyroid function that cannot be appropriately managed with medication, in the Investigator's opinion.
  • Active autoimmune disease or condition requiring chronic immunosuppressive therapy, such as rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.
  • NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
  • Clinically significant infections, including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C
  • Current treatment with an investigational therapy on another clinical trial
  • Pregnancy or breastfeeding
  • Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Houston Methodist

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Westchester Medical Center

    Valhalla, New York, 10595

Other trials in United States

About this study

Official title: A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma

CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic cells, which have been co-electroporated with both in vitro transcribed (IVT) RNA from an autologous tumor specimen and CD40L RNA. CMN-001 is indicated for treatment of intermediate/poor risk patients with advanced renal cell carcinoma (RCC) in combination with nivolumab plus ipilimumab as first line therapy and in combination with lenvatinib plus everolimus as 2nd line therapy post 1st line failure.

Being tested
CMN-001, Nivolumab+Ipilimumab, Lenvatinib+Everolimus

What participants receive

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

  • CMN-001Biological

    Autologous Dendritic Cell Therapy

  • Nivolumab+IpilimumabBiological

    anti-PD-1 and anti-CTLA4 antibodies

  • Lenvatinib+EverolimusDrug

    TKI+mTOR inhibitors

Study groups in NCT04203901
Study groupRoleWhat they receive
Combination ArmExperimentalCMN-001 dosing (1x10^7 DC/dose) is initiated at Visit 2 during 1st line therapy and through 2nd line therapy. CMN-001 is administered as 1 dose every 3 weeks for 3 doses (Induction phase), followed by maintenance doses, 1 every 4 weeks for 7 doses (Maintenance phase), followed by booster doses, 1 dose every 12 weeks (Booster phase). 1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression, 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.
Receives: Biological: CMN-001; Biological: Nivolumab+Ipilimumab; Drug: Lenvatinib+Everolimus
Standard TreatmentActive comparator1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.
Receives: Biological: Nivolumab+Ipilimumab; Drug: Lenvatinib+Everolimus

What is being measured

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

  1. Overall Survival

    Patients will be followed for OS until the completion of the study.

    Measured: Through study completion, an average of 2 years

Secondary outcomes (3)

  1. Monitor treatment emergent adverse events between both arms

    Compare adverse events between both arms

    Measured: Through study completion, an average of 2 years

  2. Progression free survival

    Progression-free survival from the date of subject randomization as assessed by the investigator per iRECIST.

    Radiological evidence of progression will be derived from tumor imaging assessments at baseline (Screening, Week 0) and restaging scans at Week 13, 21, 29, 37 then every 12 weeks until progression or study withdrawal.

    Measured: Through study completion, an average of 2 years

  3. Tumor Response

    To compare tumor responses based on iRECIST between study arms

    Measured: Through study completion, an average of 2 years

Timeline

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

  1. First posted18 Dec 2019
  2. Study start22 Jul 2020
  3. Primary completion28 Sep 2023
  4. Study completion28 Sep 2023

Why it stopped: Strategic corporate decision

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04203901
Sponsor's protocol ID
CMN-001-1
Status last verified
Sep 2023
First submitted
10 Dec 2019
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CMN-001, Nivolumab+Ipilimumab and Lenvatinib+Everolimus in people with Advanced Renal Cell Carcinoma, run by CoImmune at 9 sites in United States.

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 25 inclusion and 36 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: stopped early, as of the sponsor's last update on 2 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 9 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Strategic corporate decision). Results are not available in the source record.

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?

Overall Survival (time frame: Through study completion, an average of 2 years). 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 NCT04203901.

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 2 Oct 2023.

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