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Malignant MelanomaPhase 2NCT01480323

A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2

A Phase 2 study testing Interleukin-2 and Ipilimumab in people with Malignant Melanoma, run by University Hospital Tuebingen 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 current clinical trial shall clarify a synergistic effect with regards to efficiency by the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous application of ipilimumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Interleukin-2 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteGermany
Study dates
Feb 2012to Jun 2015
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

  • Willing and able to give written informed consent;
  • Histological diagnosis of malignant melanoma;
  • Stage IV melanoma;
  • At least one injectable lesions > 5 mm (longest diameter) or at least 5 injectable lesions < 5 mm.
  • Measurable disease. Note: lesions, which are designated for direct IL -2 injections, must not be considered in the evaluation of measurability;
  • Men and women, at least 18 years of age;
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  • Patient must have demonstrated 1 of the following in response to at least 1 cycle of 1 or more systemic regimens:
  • relapse following an objective response (PR/CR);
  • failed to demonstrate an objective response (PR/CR); or
  • inability to tolerate treatment due to unacceptable toxicity
  • At least 4 weeks since treatment (chemotherapy, biochemotherapy, surgery, radiation, immunotherapy, etc.) for melanoma and recovered from any clinically significant toxicity experienced during treatment;
  • Life expectancy ≥3 months;
  • ECOG performance status of 0 or 1;
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab;
  • No known active or chronic infection with HIV, Hepatitis B, or Hepatitis C
  • Required values for initial laboratory tests:
  • Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for up to 26 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized

Who cannot join

  • Any other prior malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix;
  • Ocular melanoma; mucosal melanoma
  • Either untreated or symptomatic central nervous system (CNS) metastases (patients with brain metastases who are identified at screening may be rescreened after the lesion(s) have been appropriately treated);
  • Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome). Patients with vitiligo may be included.
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
  • Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
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  • A history of prior systemic treatment with ipilimumab, CD137 agonist, CTLA 4 inhibitor, CTLA-4 agonist or IL-2 in stage IV melanoma.
  • Concomitant or less than 4 weeks off therapy with any of the following: interferon; other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; chronic use of systemic corticosteroids.
  • Women of childbearing potential (WOCBP), defined in Section 5.3, who:
  • are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or
  • have a positive pregnancy test at baseline, or
  • are pregnant or breastfeeding.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious) illness.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2 in Pretreated Patients With Stage IV Melanoma

The current clinical trial shall clarify a synergistic effect with regards to efficiency by the combination of intratumoral injection of interleukin-2 (IL-2) and the intra-venous application of ipilimumab.

Read the detailed description

Intratumoral injection of interleukin-2 (IL-2) into melanoma metastases is a highly efficient local treatment. Furthermore, a systemic effect is assumed based on the observation of a favorable long term outcome. However, objective responses in untreated lesions have not been observed yet. Ipilimumab seems to be efficient in a subset of treated patients by inhibition of down-regulation of tumor-specific cellular immune-responses. In the context of the proposed trial, we assume (i) that ipilimumab could potentiate systemic melanoma-specific immune responses, which are primarily induced by intratumoral IL-2 and (ii) that these immune responses become more effective with regards to not IL-2 injected distant lesions. Therefore we assume a synergistic effect with regards to efficiency by the combination.

Being tested
Interleukin-2, Ipilimumab
Keywords
Malignant melanoma
Medical subject headings
Melanoma

What participants receive

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

  • Interleukin-2Drug

    Also called Proleukin®

    intratumoral injections of 9 MIU/day on days 1, 4, 8, 11, 15, 18, 22 and 25. The administered dose will be distributed between all injectable soft-tissue metastases

  • IpilimumabDrug

    Also called Proleukin

    IV infusion, 3 mg/kg, day 2, 23, 44, 65

Study groups in NCT01480323
Study groupRoleWhat they receive
IpilimumabExperimentalIpilimumab i.v. + Interleukin-2 intratumoral
Receives: Drug: Interleukin-2; Drug: Ipilimumab

What is being measured

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

  1. Control rate

    To determine efficacy of the combined treatment with ipilimumab and intratumoral IL-2 by assessment of Disease control rate according to immune-related response criteria (irDCR) at week 12

    Measured: at week 12

Secondary outcomes (10)

  1. Tolerability

    Tolerability according to NCI-CTCAE-Criteria (version 4)

    Measured: within 12 months after start of treatment

  2. Overall survival

    Overall survival

    Measured: within 12 months after start of treatment

  3. Best Overall Response Rate

    Best Overall Response Rate (irBORR) according to irRC

    Measured: within 12 months after start of treatment

  4. Overall response rate

    Overall response rate (sum of irPR and irCR) according to irRC

    Measured: at week 12

  5. Overall Response Rate

    Overall Response Rate according to modified mWHO criteria

    Measured: at week 12

  6. Best Overall Response Rate

    Best Overall Response Rate according to modified mWHO criteria

    Measured: within 12 months after start of treatment

  7. Response rate of injected metastases only

    Response rate of injected metastases only

    Measured: at week 12

  8. Rate of patients with substantial increase of anti-melanoma T-cells in peripheral blood during treatment

    Rate of patients with substantial increase of anti-melanoma T-cells in peripheral blood during treatment

    Measured: within 22 weeks after start of treatment

  9. Changes in T-cell subsets during treatment

    Changes in T-cell subsets during treatment

    Measured: within 22 weeks after start of treatment

  10. Changes in subsets of tumor-infiltrating lymphocytes during treatment

    Changes in subsets of tumor-infiltrating lymphocytes during treatment

    Measured: within 22 weeks after start of treatment

Timeline

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

  1. First posted28 Nov 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2014
  4. Study completionJun 2015

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480323
Sponsor's protocol ID
5027000
Status last verified
Jul 2015
First submitted
23 Nov 2011
Last updated
21 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin-2 and Ipilimumab in people with Malignant Melanoma, run by University Hospital Tuebingen 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 17 inclusion and 13 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 21 Jul 2015. 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 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 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?

Control rate (time frame: at week 12). 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 NCT01480323.

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 21 Jul 2015.

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