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Advanced CancersPhase 1NCT01750983

Ipilimumab and Lenalidomide in Advanced Cancer

A Phase 1 study testing Ipilimumab and Lenalidomide in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site 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 this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancers
What is being tested?
Ipilimumab and Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteUnited States
Study dates
Mar 2013to 21 Feb 2019
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

  • Patients with advanced or metastatic cancers with no available standard therapy are eligible to enter the Phase 1 portion of this study.
  • Patients must be >/= 18 years.
  • Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. A confirmation (written or verbal) that there is no risk of surgical complications from a patient's surgeon has to be obtained prior to starting therapy in patients with a history of major surgery within past 6 weeks. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be >/= 5 half-lives or >/= 3 weeks form the last dose (whichever comes first).
  • ECOG performance status </= 2.
  • Patients must have adequate organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL platelets >/=50,000/mL; CrCl >/=60mL/min by Cockcroft -Gault calculation; total bilirubin </= 2x ULN (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT(SGPT) </= 5X ULN; willingness to participate in the RevAssist® program. Females: two effective contraceptive methods should be used during therapy, during therapy interruptions, and for at least 4 weeks after completing therapy. Males: must always use a latex condom during any sexual contact with females of childbearing potential, even if they have undergone a successful vasectomy.
  • Patients must be able to understand and be willing to sign a written informed consent document.

Who cannot join

  • Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  • Pregnant or lactating women.
  • History of hypersensitivity to ipilimumab.
  • History of hypersensitivity to lenalidomide.
  • Patients unwilling or unable to sign informed consent document.
  • Patients on hemodialysis.
Show all 11Show fewer
  • History of organ transplantation.
  • History of autoimmune disease, including inflammatory bowel disease.
  • History of severe motor or sensory neuropathy, or any other autoimmune disorder which is deemed to be significant.
  • Patients with a prior history of Grade 4 rash associated with thalidomide treatment.
  • History of Angioedema.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I Trial of Ipilimumab (Anti CTLA- 4 Antibody) in Combination With Lenalidomide (IMiD) in Patients With Advanced Malignancies

The goal of this clinical research study is to find the highest tolerable dose of the combination of Yervoy® (ipilimumab) with Revlimid® (lenalidomide) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.

Ipilimumab is designed to increase the immune system's ability to fight cancer.

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.

Read the detailed description

Study Groups:

Dose escalation:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drugs based on when you join the study.

Up to 5 dose levels of ipilimumab with lenalidomide will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ipilimumab with lenalidomide is found.

Dose expansion:

Once the highest tolerable dose of ipilimumab with lenalidomide is found, up to 14 more participants may be enrolled. This will be to further study the safety of the combination of drugs at that dose and the level of effectiveness of the study drugs in a certain tumor group. This group will be called the dose expansion group.

Study Drug Administration:

Each study cycle is 28 days.

You will take lenalidomide by mouth on Days 1-21 of each cycle. You will swallow the capsules whole with water once a day. Do not break, chew, or open your capsules. The doctor will discuss this with you.

You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle. You will be monitored for side effects for 1-2 hours after the infusion.

Study Visits:

Every study visit:

° You will be asked if you have had any side effects.

Cycle 1:

  • On Day 1: blood (about 4 teaspoons) will be drawn for routine tests.
  • Between Days 2 and 7: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
  • Between Days 8 and 14: Blood (about 4 teaspoons) will be drawn for routine tests. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
  • Between Days 15 and 21: Blood (about 4 teaspoons) will be drawn for routine tests. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
  • Between Days 22 and 28: Blood (about 4 teaspoons) will be drawn for routine tests. Your medical history will be recorded.

Cycle 2:

  • On Day 1: Blood (about 4 teaspoons) will be drawn for routine tests.
  • On Day 8 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
  • On Day 15 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.
  • On Day 22 (+/- 3 days): Blood (about 4 teaspoons) will be drawn for routine tests.

Every other cycle (every 8 weeks):

° You will have an x-ray, CT scan, and/or PET/CT scan to check the status of the disease. ° Blood (about 1 tablespoon) will be drawn for tumor marker testing.

Before starting Cycle 3 and all following cycles:

  • Your medical history will be recorded.
  • You will have a physical exam, including measurement of your weight and vital signs.
  • You will be asked about any health problems you may have and any other drugs or herbal supplements you may be taking.
  • Your performance status will be recorded.
  • Blood (about 4 teaspoons) will be drawn for routine tests. Blood may be drawn more often if your doctor thinks it is needed.
  • If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

At the End of the study:

  • Directly at the end of the study: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
  • 28 days after therapy with lenalidomide stopped: If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Length of Dosing:

You may receive up to 4 doses of ipilimumab. You may continue receiving lenalidomide for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You will be off study after your follow-up visit.

Follow-up:

You will have a follow-up-visit within 30 days after your last dose of study drugs. You will be asked about any health problems you may have and if you have had any side effects. If your study doctor thinks it is needed, you may have follow-up for a longer period of time. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

This is an investigational study. Ipilimumab is FDA approved and commercially available to treat metastatic melanoma. Lenalidomide is FDA approved and commercially available to treat multiple myeloma and myelodysplastic syndrome. Giving the combination of ipilimumab and lenalidomide to patients with advanced cancer is investigational.

Up to 101 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Keywords
Advanced Cancers, Advanced Malignancies, Metastatic cancers, Ipilimumab, Yervoy, BMS-734016, MDX010, Lenalidomide, CC-5013, Revlimid
Medical subject headings
Neoplasms

What participants receive

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

  • IpilimumabDrug

    Also called Yervoy, BMS-734016, MDX010

    Dose Escalation Group Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle.

    Dose Expansion Group Starting Dose for Ipilimumab: Maximum tolerated dose (MTD) from Dose Escalation Group.

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    Dose Escalation Group Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle.

    Dose Expansion Group Starting Dose for Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Group.

Study groups in NCT01750983
Study groupRoleWhat they receive
Ipilimumab + LenalidomideExperimentalDose Escalation Group Ipilimumab Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle. Dose Escalation Group Lenalidomide Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle. Dose Expansion Group Starting Dose for Ipilimumab and Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Groups.
Receives: Drug: Ipilimumab; Drug: Lenalidomide

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide

    Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of dose limiting toxicity (DLT) was less than 33%.

    Measured: 28 days

  2. Dose-Limiting Toxicities (DLT) of Ipilimumab in Combination With Lenalidomide

    Dose-limiting toxicity (DLT) defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in NCI CTC v4.0, expected and believed to be related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 hematologic toxicity lasting at least 3 weeks or longer (as defined by the NCI-CTC v4.0) or associated with bleeding and/or sepsis; any grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE v4.0 that is attributable to the therapy.

    Measured: 28 days

Secondary outcomes (1)

  1. Tumor Response

    Rumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria

    Measured: Every 8 weeks

Timeline

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

  1. First posted17 Dec 2012 (estimated)
  2. Study startMar 2013
  3. Primary completion21 Feb 2019
  4. Study completion21 Feb 2019

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
Masking
None (open label)
Enrolment
101 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01750983
Sponsor's protocol ID
2012-0795
Other IDs
NCI-2013-00607
Status last verified
Feb 2019
First submitted
13 Dec 2012
Last updated
25 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ipilimumab and Lenalidomide in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site 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 6 inclusion and 11 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 25 Feb 2019. 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 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 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?

Maximum Tolerated Dose (MTD) of Ipilimumab in Combination With Lenalidomide (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT01750983.

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 25 Feb 2019.

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