Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL
Active, enrolledPhase 2Results postedLast updated 20 October 2025
What this trial tests
Phase 2 trial testing Carboplatin in Recurrent Hodgkin Lymphoma in 78 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Recurrent Hodgkin Lymphoma or Refractory Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response Rate by Lugano ClassificationPrimary· From the initial treatment to the end of the treatment, up to 6 months.
Complete response rates were calculated as the percent of evaluable patients that have confirmed complete response by radiographic response including computed tomography and/or positron emission tomography scans; 95% Clopper Pearson confidence limits were calculated for this estimate.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
71
55 – 84
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
88
71 – 96
Number of Participants With Unacceptable Adverse EventsPrimary· From initial treatment to the end of the study, up to 77 months.
Toxicities were assessed and reported using the Bearman (non-hematologic) and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scales. Unacceptable toxicity in a given patient is defined as any non-hematologic or hematological grade 3/4 toxicity that did not resolve to a grade 1/2 within 14 days per NCI CTCAE v4.03 toxicity criteria and was considered at least possibly related to nivolumab and/or ICE, or any other regimen-related cause of death.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
0
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
0
Overall Response RateSecondary· From the initial treatment to the end of the treatment, up to 6 months.
Overall response rate was calculated as the percent of evaluable patients that have confirmed complete response or partial remission by radiographic response including computed tomography and/or positron emission tomography scans; 95% Clopper Pearson confidence limits were calculated for this estimate.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
81
66 – 91
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
100
89 – 100
Two-Year Overall Survival (OS) RateSecondary· 2 years from start of treatment
Overall survival (OS) is defined as the duration of time from start of study treatment to time of death (due to any cause). OS rate was estimated using the product-limit method of Kaplan and Meier. The event is death.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
95
82 – 99
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
100
100 – 100
Two-Year Progression-Free Survival (PFS) RateSecondary· 2 years from start of treatment
Progression-free survival is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first. PFS rate was estimated using the product-limit method of Kaplan and Meier. The event is progression/relapse or death.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
72
56 – 83
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
94
77 – 98
Two-Year Progression-Free Survival Rate (Post Autologous Transplant)Secondary· From start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years.
Progression-free survival (PFS) is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first. PFS rate was estimated using the product-limit method of Kaplan and Meier. The event is post-transplant progression/relapse or death.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
94
77 – 98
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
97
80 – 100
Cumulative Incidence of Relapse/Progression at 2 YearsSecondary· 2 years from start of treatment
The cumulative incidence of relapse/progression was calculated as competing risks using the method of Gooley et al. The event is relapse/progression. Deaths without relapse/progression are considered a competing risk.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
9
4 – 24
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
6
2 – 24
Non-relapse Mortality (NRM) at 2 YearsSecondary· 2 years from start of treatment
The cumulative incidence of non-relapse mortality was calculated as competing risks using the method of Gooley et al. NRM is defined as death occurring in a patient from causes other than relapse or progression. Deaths from relapse/progression are considered a competing risk.
Group
Value
95% CI
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
2
0.3 – 16
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
0
0 – 0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Serious: 5/43 (12%)
Deaths: 2/43
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Serious: 3/35 (9%)
Deaths: 0/35
Serious adverse events (12 terms)
Reaction
System
Cohort A (Nivolumab, Etopo…
Cohort B (Nivolumab, Etopo…
Fever
General disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Adrenal insufficiency
Endocrine disorders
—
—
Thyroiditis
Endocrine disorders
—
—
Colitis
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Altered Mental Status
Nervous system disorders
—
—
Unintended pregnancy
Pregnancy, puerperium and perinatal conditions
—
—
Renal Failure
Renal and urinary disorders
—
—
Aspiration, Intubation
Respiratory, thoracic and mediastinal disorders
—
—
Pneumonia
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (162 terms — click to expand)
This phase II trial studies the side effects of nivolumab and to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin lymphoma that has come back (relapsed) and does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ifosfamide, carboplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab, ifosfamide, carboplatin and etoposide may work better in treating patients with Hodgkin lymphoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma
· Phase 2
· withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
· Phase 3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
Other recruiting trials for Recurrent Hodgkin Lymphoma
Currently open trials in the same condition.
NCT05272384 — Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
· Phase 1
· recruiting
NCT04871607 — Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Prima
· Phase 2
· recruiting
NCT04640779 — Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or R
· Phase 1
· active not recruiting
NCT03418038 — Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Le
· Phase 2
· recruiting
NCT03057795 — Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
· Phase 2
· active not recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 20 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03016871.