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Metastatic MelanomaPhase 2NCT03122522

A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy

A Phase 2 study testing ipilimumab and nivolumab in people with Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. 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?
ipilimumab and nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
13 sitesUnited States
Study dates
17 Apr 2017to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologic diagnosis of unresectable III or stage IV metastatic melanoma.
  • Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).
  • No prior CTLA-4 or PD-1/PD-L1 therapy for the treatment of metastatic disease.
  • ECOG performance status of 0-1.
  • Life expectancy ≥ 4 months.
  • Screening laboratory parameters:
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  • White blood cell (WBC) count ≥ 2000/μL;
  • Absolute neutrophil count (ANC) ≥ 1500/μL;
  • Platelets ≥ 100,000/μL;
  • Hemoglobin (Hgb) ≥ 9 g/dL;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
  • Total bilirubin ≤ 1.5 × ULN (< 3 mg/dL for subjects with Gilbert's disease);
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dL] Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dL]
  • Age ≥ 18 years.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 23 weeks after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
  • [Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).] Nonsterilized males who are sexually active with a female partner of childbearing potential must use 2 acceptable methods of effective contraception from Day 1 and for 31 weeks after receipt of the final dose of investigational product.
  • Acceptable methods of effective contraception are described in the following table:
  • Barrier Methods - Male condom plus spermicide, cap plus spermicide, or diaphragm plus spermicide.
  • Intrauterine Device Methods-Copper T, or Levonorgestrel-releasing intrauterine system (e.g., Mirena®), also considered a hormonal method.
  • Hormonal Methods-Implants, hormone shot or injection, combined pill, minipilimumabll, or Patch.

Who cannot join

  • Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome, Myasthenia Gravis).
  • Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
  • Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C infection. Antibody to Hepatitis B or C without evidence of active infection may be allowed.
  • History of severe allergic reactions to any unknown allergens or any components of the study drugs.
  • Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders).
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  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival.
  • Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).
  • Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • JOHNS HOPKINS HOSPITAL (Data Analysis Only)

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Brigham and Women's Hospital (Data and Specimen Analysis Only)

    Boston, Massachusetts, 02115

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Hartford Healthcare Alliance (Data Collection Only)

    Hartford, Connecticut, 06102

  • Jaykumar Thumar

    Hartford, Connecticut, 06102

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Hospital for Special Surgery (Data Analysis)

    New York, New York, 10021

  • Columbia University (Data Analysis Only)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase II Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy

This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. If patients do not show early benefit after 2 doses, patients will be able to continue with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best interest of the patient.

Being tested
ipilimumab, nivolumab
Keywords
unresectable, III or stage IV, Ipilimumab, Nivolumab, 17-162
Medical subject headings
Melanoma

What participants receive

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

Study groups in NCT03122522
Study groupRoleWhat they receive
ipilimumab and nivolumabExperimentalPts will receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks. Week 6, if pts have achieved a favorable antitumor effect by RECIST will begin maintenance nivolumab alone at 480mg every 4 weeks for 2 doses (week 6 \& week 10) \& repeat response assessments at week 12. If pts don't achieve a favorable antitumor effect at week 6, pt will get 2 additional doses of ipilimumab + nivolumab every 3 weeks \& then will be assessed for response at week 12. If pts haven't achieved a favorable antitumor effect by week 12, if felt in the best interest for the pt as determined by the PI, pts may continue getting additional doses of ipilimumab + nivolumab with response reassessments after every 2 doses. Maintenance nivolumab will continued until unacceptable toxicity or confirmed disease progression. If pts have had an initial clinical benefit from therapy \& subsequently experience progressive disease at any time, reinduction with combination ipilimuma+ nivolumab will be allowed.
Receives: Drug: ipilimumab; Drug: nivolumab

What is being measured

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

  1. objective response rate

    RECIST 1.1.

    Measured: at 6 weeks

Timeline

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

  1. First posted20 Apr 2017
  2. Study start17 Apr 2017
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122522
Sponsor's protocol ID
17-162
Status last verified
Sep 2026
First submitted
18 Apr 2017
Last updated
8 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pandit-Taskar N, Mauguen A, Frosina D, Jungbluth A, Busam KJ, Lyashchenko S, Schwartz J, Momtaz P, Warner AB, Smithy JW, Shoushtari AN, Callahan MK, Chapman PB, Postow MA. Programmed death ligand-1 PET imaging in patients with melanoma: a pilot study. Melanoma Res. 2025 Oct 1;35(5):328-338. doi: 10.1097/CMR.0000000000001050. Epub 2025 Jun 25.

    PubMed 40557547

  • Postow MA, Goldman DA, Shoushtari AN, Betof Warner A, Callahan MK, Momtaz P, Smithy JW, Naito E, Cugliari MK, Raber V, Eton O, Nair SG, Panageas KS, Wolchok JD, Chapman PB. Adaptive Dosing of Nivolumab + Ipilimumab Immunotherapy Based Upon Early, Interim Radiographic Assessment in Advanced Melanoma (The ADAPT-IT Study). J Clin Oncol. 2022 Apr 1;40(10):1059-1067. doi: 10.1200/JCO.21.01570. Epub 2021 Dec 20.

    PubMed 34928709

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ipilimumab and nivolumab in people with Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 13 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 20 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

This study is still under way. Results are not available in the source record yet.

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?

objective response rate (time frame: at 6 weeks). 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 NCT03122522, which also lists 2 linked publications.

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 8 Sep 2026.

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