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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03122522
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 17, 2017
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ipilimumab and nivolumab
    Pts 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.

Primary Outcome Measure

objective response rate [ Time Frame: at 6 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Alliance (Data Collection Only)HartfordConnecticut06102-
Jaykumar ThumarHartfordConnecticut06102-
JOHNS HOPKINS HOSPITAL (Data Analysis Only)BaltimoreMaryland21287-
Brigham and Women's Hospital (Data and Specimen Analysis Only)BostonMassachusetts02115-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Columbia University (Data Analysis Only)New YorkNew York10032-
Hospital for Special Surgery (Data Analysis)New YorkNew York10021-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-
Lehigh Valley Health Network (Data Collection Only)AllentownPennsylvania18103-

Find similar trials in Hartford, CT

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Hartford Healthcare Alliance (Data Collection Only)· Hartford, CTJaykumar Thumar· Hartford, CTJOHNS HOPKINS HOSPITAL (Data Analysis Only)· Baltimore, MDBrigham and Women's Hospital (Data and Specimen Analysis Only)· Boston, MAMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJ

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