2025-03-17
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v8
Primary completion date2024-03-01→2024-04-01
Results first postednot stated→2025-04-03
Secondary endpoints11 entries, revised
Overall responseResponse rateRate (ORR) Ipilimumab monotherapyMonotherapy, Lugano
PartialOverall Response rateRate (PRRORR) Ipilimumab monotherapyMonotherapy, LYRIC
Complete Response rateRate (CRR) Ipilimumab monotherapyMonotherapy, Lugano
Complete Response Rate (CRR) Ipilimumab Monotherapy, LYRIC
Overall responseResponse rateRate (ORR) ipilimumabIpilimumab and nivolumabNivolumab combinationCombination therapyTherapy, Lugano
PartialOverall Response rateRate (PRRORR) ipilimumabIpilimumab and nivolumabNivolumab combinationCombination therapyTherapy, LYRIC
CompleteProgression-free ResponseSurviva [...] [...]
Primary endpoints1 entry, revised
Overall responseResponse rateRate (ORR) after 4 cycles of ipilimumab monotherapy
2024-03-18
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
Show 5 earlier versions
2023-05-12
minor
Study Status, Contacts/Locations v5
2023-02-06
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Enrollment target32→13
Study arms2→1
Eligibility criteria-755 characters
[...] ncluding autologous stem cell transplantation, if eligible.
Patients must have received a prior PD-1 monoclonal antibody, with the following specific requirements for each cohort.
Cohort 1
Received at least 18 weeks of single-agent PD-1 mAb (with last dose within 12 weeks)
Underwent a restaging PET scan at least 18 weeks after initiation of PD-1 monotherapy [...] Progression of disease or relapse following treatment with nivolumab or pembrolizumab.
Intervening treatments with between PD-1 mAb therapy and the trial are permitted.
Patie [...] body-based therapy, etc.), or 56 days for radioimmunotherapy (Note [...] [...]
Secondary endpoints18 to 11 entries
Best Overall response rate (ORR)-Cohort 1
Best Partial Response rate (PRR)-Cohort 1
Best Complete Response rate (CRR)-Cohort 1
6-month progression-free survival Lyric Criteria-Cohort 1
Duration of response (DOR)-Cohort 1
Overall response rate (ORR) Ipilimumab monotherapy-Cohort 2
Partial Response rate (PRR) Ipilimumab monotherapy-Cohort 2
Complete Response rate (CRR) Ipilimumab monotherapy-Cohort 2
Overall response rate (ORR) ipilimumab and nivolumab combination therapy-Cohort 2
Partial Response rate (PRR) ipilimumab and nivolumab combination therapy-Cohort 2
Complete Response rate (CRR) ipili [...] [...]
Primary endpoints2 to 1 entries
6-month Progression Free Survival (PFS)-Cohort 1
Overall response rate (ORR) after 4 cycles of ipilimumab monotherapy -Cohort 2
Study description-573 characters
This is an open-label, multi-cohort, multi-center, phase II study of ipilimumab with or without [...] bination for cHL by the Food and Drug Administration (FDA).
PatientsThis will be divided into two cohorts based on prior response to PD-1 monoclonal antibody (mAb) therapy:
Cohort 1 is for participants who are receiving a PD-1 mAb and have achieved either stable disease or a partial response after at least 18 weeks of PD-1 mAb therapy.
Cohort 2study is for participants who previously had progressive disease when receiving a PD-1 mAb.
Participants in cohort 1 will receive 4 cycles of nivolumab and ipi [...] [...]
2022-10-18
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v3
Primary completion date2024-09-01→2024-03-01
Start date2021-09-01→2021-06-04
Secondary endpointsdetails revised at 6 of 18 entries
Study description+186 characters
[...] nd ipilimumab followed by ipilimumab maintenance treatment.
Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable.
Participants in cohort 2 will receive up to ~ 24 months of s [...]
2022-04-08
minor
Study Status, Study Description, Eligibility, Contacts/Locations v2
Eligibility criteria+105 characters
[...] ng specific requirements for each cohort.
Cohort 1
Received at least 18-30 weeks of single-agent PD-1 mAb (with last dose within 12 weeks)
Underwent a restaging PET scan at least 18-30 weeks after initiation of PD-1 monotherapy which demonstrat [...] body-based therapy, etc.), or 56 days for radioimmunotherapy (Note: Patients in Cohort 1 may have received a PD-1 mAb within 3 weeks of study initiation).
Steroids for symptom palliation are allowed but must be ei [...]
Study description-5 characters
[...] achieved either stable disease or a partial response after approximatelyat 6least months18 weeks of PD-1 mAb therapy.
Cohort 2 is for participants who previ [...]
Study sitesdetails revised at 1 of 3 sites
2021-09-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 3 of 3 sites