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Metastatic MelanomaPhase 2NCT02644967

A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma

A Phase 2 study testing IMO-2125 and Ipilimumab in people with Metastatic Melanoma, run by Idera Pharmaceuticals, Inc. at 10 sites in United States.

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 goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
IMO-2125 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
10 sitesUnited States
Study dates
Dec 2015to May 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients must have histologically confirmed metastatic melanoma with measurable, stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease.
  • Patients must have symptomatic or radiographic progression during or after treatment with a PD-(L)1 inhibitor administered either as monotherapy or in combination.
  • The interval between last PD-(L)1 directed treatment and start of study treatment should be at least 21 days.
  • Prior BRAF or MEK inhibitor treatment is not required. However, for patients with known BRAF status:
  • Those with BRAF wild type may have had a maximum of two previous systemic regimens for the treatment of melanoma.
  • Those with a BRAF mutation may have had a maximum of three previous systemic regimens for the treatment of melanoma.
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  • Prior ipilimumab is permitted.
  • Previous treatment with either a PD-1 inhibitor (for patients enrolling on the IMO-2125 + pembrolizumab combination) or CTLA-4 inhibitor (for patients enrolling on the IMO-2125 + ipilimumab combination if applicable) should not have been accompanied by DLT for which permanent discontinuation is recommended (per USPI).
  • Patients with a history of Grade ≥2 gastrointestinal symptoms (e.g., diarrhea, colitis) during prior checkpoint inhibitor treatment should be discussed with the Idera Medical Monitor during the Screening Period before starting study treatment.
  • Phase 1 patients must have at least two measurable tumor lesions ≥ 1.0 cm that are accessible to biopsy. Phase 2 patients must have at least one measurable lesion (per RECIST v1.1) which may be the same site that is used for the intratumoral injections.
  • Patients must be ≥ 18 years of age.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Patients must meet the following laboratory criteria:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1500/mm3)
  • Platelet count ≥ 75 x 10^9/L (75,000/mm3)
  • Hemoglobin ≥ 8.0 g/dL (4.96 mmol/L)
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/minute
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement
  • Serum bilirubin ≤ 1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL
  • Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 90 days after the last dose of IMO-2125, 3 months after the last dose of ipilimumab or at least 4 months after the last dose of pembrolizumab.
  • Patients must have an anticipated life expectancy > 3 months.

Who cannot join

  • Patients who have received prior therapy with a TLR agonist, excluding topical agents. Patients who have received experimental vaccines or other investigational immune therapies should be discussed with the Medical Monitor to confirm eligibility.
  • Patients who have received systemic treatment with IFN-α within the previous 6 months prior to enrolling into this study.
  • Patients with known hypersensitivity to any oligodeoxynucleotide.
  • Patients with active autoimmune disease requiring disease-modifying therapy.
  • Patients requiring concurrent systemic steroid therapy higher than physiologic dose (7.5 mg/day of prednisone).
  • Patients with any form of active primary or secondary immunodeficiency.
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  • Patients with another primary malignancy that has not been in remission for at least 3 years.
  • Patients with active systemic infections requiring antibiotics or active hepatitis A, B, or C.
  • Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Patients who previously had a severe reaction to treatment with a human antibody.
  • Patients with known central nervous system, meningeal, or epidural disease.
  • Women who are pregnant or breastfeeding.
  • Patients with impaired cardiac function or clinically significant cardiac disease.
  • Patients with ocular melanoma.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Icahn School Of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Utah- Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Moffitt Cancer Center Research Institute

    Tampa, Florida, 33612

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma (ILLUMINATE-204)

The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.

Read the detailed description

The open-label single-arm Phase 2 study was designed to assess the recommended dose for safety, tolerability, pharmacokinetics (PK), immunogenicity, and efficacy of 8 mg IMO-2125 (tilsotolimod) when administered in combination with ipilimumab.

Being tested
IMO-2125, Ipilimumab
Keywords
ILLUMINATE- 204, IMO-2125, tilsotolimod
Medical subject headings
Melanoma

What participants receive

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

  • IMO-2125Drug

    Also called tilsotolimod (tilso)

    Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

  • IpilimumabDrug

    Also called Yervoy®

    4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Study groups in NCT02644967
Study groupRoleWhat they receive
Phase 2, 8 mg Tilso/IpiExperimentalIMO-2125 intratumoral injection plus ipilimumab
Receives: Drug: IMO-2125; Drug: Ipilimumab

What is being measured

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

  1. Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1

    The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

    • The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44)
    • The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

    The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi was calculated using the participant's best overall response (BOR).

    Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - >=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions.

    Overall Response = CR or PR

    Measured: 33 weeks (29 weeks of treatment, 4 weeks follow up)

Secondary outcomes (3)

  1. Phase 2: Progression-free Survival

    The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

    • The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable)
    • The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

    Progression-free survival was defined as the number of months from the initiation of treatment to confirmed disease progression using RECIST v1.1 or death from any cause.

    Measured: 33 weeks (29 weeks of treatment, 4 weeks follow up)

  2. Phase 2: Overall Survival - 6 Months

    The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

    • The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=44 (40 with 4 non-evaluable)
    • The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

    Overall survival was defined as the number of months from initiation of treatment to death from any cause.

    Measured: 6 months

  3. Phase 2: Overall Survival - 12 Months

    The following combined analysis populations were used for outcome measures (efficacy analysis N=53):

    • The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable)
    • The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9)

    Overall survival was defined as the number of months from initiation of treatment to death from any cause.

    Measured: 12 months

Timeline

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

  1. First posted1 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionFeb 2020
  4. Study completionMay 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02644967
Sponsor's protocol ID
2125-204
Other IDs
ILLUMINATE-204
Status last verified
Jul 2022
First submitted
23 Dec 2015
Last updated
3 Aug 2022
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 IMO-2125 and Ipilimumab in people with Metastatic Melanoma, run by Idera Pharmaceuticals, Inc. at 10 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 21 inclusion and 14 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Yes. Results are posted in the registry (first posted 3 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 (time frame: 33 weeks (29 weeks of treatment, 4 weeks follow up)). 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 NCT02644967.

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 3 Aug 2022.

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