Drugs / Dacarbazine
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Dacarbazine

Small molecule

Developed for
melanoma · classic Hodgkin lymphoma · Hodgkins lymphoma · lymphoma · cutaneous melanoma · metastatic melanoma · soft tissue sarcoma · neuroblastoma
+31 more · leiomyosarcoma · sarcoma · Hodgkin's lymphoma, lymphocytic depletion · Hodgkin's lymphoma, mixed cellularity · nodular sclerosis classical Hodgkin lymphoma · iris melanoma · medium/large size posterior uveal melanoma · peripheral T-cell lymphoma, not otherwise specified · skin cancer · small size posterior uveal melanoma · synovial sarcoma · adult nodular lymphocyte predominant Hodgkin lymphoma · bone sarcoma · breast cancer · colonic neoplasm · colorectal cancer · Hodgkin's lymphoma, lymphocytic-histiocytic predominance · kidney cancer · lung cancer · malignant peripheral nerve sheath tumor · metastatic neoplasm · neuroendocrine neoplasm · ocular melanoma with extraocular extension · pancreatic neuroendocrine tumor · solitary fibrous tumor · thyroid cancer · urinary bladder cancer · urothelial carcinoma · uveal melanoma · cancer · liposarcoma
Investigated by
National Cancer Institute (NCI) · Seagen Inc. · European Organisation for Research and Treatment of Cancer - EORTC · M.D. Anderson Cancer Center · Bristol-Myers Squibb · Eastern Cooperative Oncology Group
+136 more · Fondazione Italiana Linfomi - ETS · Merck Sharp & Dohme LLC · Memorial Sloan Kettering Cancer Center · University of Cologne · Cancer and Leukemia Group B · City of Hope Medical Center · German Society for Pediatric Oncology and Hematology GPOH gGmbH · Northwestern University · Pfizer · Philogen S.p.A. · Radiation Therapy Oncology Group · SWOG Cancer Research Network · Alliance for Clinical Trials in Oncology · Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte · Children's Cancer and Leukaemia Group · Children's Oncology Group · Christine Mauz-Körholz · French Innovative Leukemia Organisation · Genta Incorporated · H. Lee Moffitt Cancer Center and Research Institute · Henan Cancer Hospital · Italian Sarcoma Group · Lymphoma Study Association · Spanish Group for Research in Sarcomas · Stanford University · Sun Yat-sen University · University of Miami · University of Washington · Academic and Community Cancer Research United · Advenchen Laboratories, LLC · Amgen · AmpliMed Corporation · Asfendiyarov Kazakh National Medical University · AstraZeneca · Australasian Leukaemia and Lymphoma Group · Bayer · Beijing Children's Hospital · Binhui Biopharmaceutical Co., Ltd. · Canadian Cancer Trials Group · Case Comprehensive Cancer Center · Celgene Corporation · Centocor, Inc. · Centre Hospitalier Universitaire Dijon · Children's Cancer Group, China · Children's Hospital Medical Center, Cincinnati · Children's Hospital of Hebei Province · Children's Hospital of Henan Province · Chugai Pharma France · ClinAssess · Consorzio Mario Negri Sud · Dartmouth-Hitchcock Medical Center · Dermatologic Cooperative Oncology Group · Deutsche AIDS Gesellschaft e.V. · Deutsche Krebshilfe e.V., Bonn (Germany) · ECOG-ACRIN Cancer Research Group · Eisai Inc. · Eudax S.r.l. · Euronet Worldwide · Exelisis · French Sarcoma Group · GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI) · Genentech, Inc. · GlaxoSmithKline · Guangzhou Gloria Biosciences Co., Ltd. · Gustave Roussy, Cancer Campus, Grand Paris · Gynecologic Oncology Group · Harlachinger Krebshilfe e.V. · Hoffmann-La Roche · Hospital JP Garrahan · Institut Bergonié · Institut Claudius Regaud · James Graham Brown Cancer Center · Janssen-Cilag Farmaceutica, S.R.L. · Jonsson Comprehensive Cancer Center · all 142 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed classic Hodgkin lymphoma 1 milestone
Filed US (FDA) Opdivo classic Hodgkin lymphoma 2025-12-11

“FDA has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo ® (nivolumab) in combination with doxorubicin, vinblastine and...” bms.com ↗

Approved Indication not stated 2 milestones
Label expansion US (FDA) DTIC-DOME — 1981-04-29 fda.gov ↗
Approved US (FDA) DTIC-DOME — 1975-05-27 fda.gov ↗

Trials 137 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT00600496 Dec 2007 → Aug 2010 breast cancer, colonic neoplasm, colorectal cancer, kidney cancer +2 AstraZeneca Completed No outcome recorded
Phase 1 NCT00542893 Apr 2006 → Sep 2007 melanoma Genta Incorporated Completed No outcome recorded
Phase 1 NCT00412581 Sep 2005 → Mar 2008 melanoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT00580320 Sep 2004 → Oct 2009 carcinoid tumor, melanoma, parathyroid gland carcinoma, small cell lung carcinoma +1 Virginia Commonwealth University Completed No outcome recorded
Phase 1/213 trials · 1 met primary
Phase 1/2 NCT03331341 Jan 2019 → Dec 2023 classic Hodgkin lymphoma University of Washington Completed Met primary
Phase 1/2 NCT03277924 May 2017 → Jun 2024 bone sarcoma, soft tissue sarcoma Spanish Group for Research in Sarcomas Completed No outcome recorded
Phase 1/2 NCT02076646 Jul 2013 → May 2016 metastatic melanoma Philogen S.p.A. Unknown No outcome recorded
Phase 1/2 NCT01771107 Mar 2013 → Oct 2021 HIV infectious disease, classic Hodgkin lymphoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT01614301 May 2012 → May 2014 melanoma University of Regensburg Unknown No outcome recorded
Phase 1/2 NCT01133977 Apr 2010 → Jun 2014 melanoma Eisai Inc. Completed No outcome recorded
Phase 1/2 NCT00597038 Nov 2007 → Sep 2011 metastatic melanoma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 1/2 NCT00615160 Dec 2006 → Sep 2008 melanoma Michael Weichenthal Terminated No outcome recorded
Phase 1/2 NCT00496223 Sep 2006 → Jun 2007 melanoma H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded
Phase 1/2 NCT00327600 Jul 2005 → Jan 2007 melanoma AmpliMed Corporation Completed No outcome recorded
Phase 275 trials · 1 met primary · 2 missed
Phase 2 NCT07847359 Oct 2026 → Dec 2028 expected cutaneous melanoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07551583 Aug 2026 → Dec 2030 expected Hodgkins lymphoma M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT07275216 Jul 2026 → Oct 2029 expected classic Hodgkin lymphoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT06835049 Oct 2025 → Mar 2028 expected soft tissue sarcoma Swiss Cancer Institute Recruiting No outcome recorded
Phase 2 NCT07002216 Jul 2025 → Jul 2030 expected Hodgkins lymphoma University of Miami Recruiting No outcome recorded
Phase 2 NCT06984146 Apr 2025 → Jan 2028 expected classic Hodgkin lymphoma National Medical Research Radiological Centre of the Ministry of Health of Russia Recruiting No outcome recorded
Phase 2 NCT06745076 Mar 2025 → Jan 2032 expected classic Hodgkin lymphoma University of Washington Recruiting No outcome recorded
Phase 2 NCT07234487 Oct 2024 → Oct 2029 expected classic Hodgkin lymphoma St. Petersburg State Pavlov Medical University Recruiting No outcome recorded
Phase 2 NCT06377566 Apr 2024 → Apr 2027 expected Hodgkins lymphoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06164275 Feb 2024 → Jul 2025 overdue classic Hodgkin lymphoma Northwestern University Active not recruiting No outcome recorded
Phase 2/32 trials · 1 missed
Phase 2/3 NCT06563245 Sep 2024 → Nov 2029 expected classic Hodgkin lymphoma Children's Cancer Group, China Recruiting No outcome recorded
Phase 2/3 NCT00784537 Sep 2008 → Jan 2015 Hodgkins lymphoma Fondazione Italiana Linfomi - ETS Completed Missed primary
Phase 334 trials · 3 met primary · 6 missed
Phase 3 NCT05675410 May 2023 → Apr 2031 expected Hodgkins lymphoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 3 NCT05868707 Mar 2023 → Mar 2026 overdue melanoma Binhui Biopharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT04685616 Apr 2022 → Sep 2030 expected Hodgkins lymphoma University College, London Recruiting No outcome recorded
Phase 3 NCT04307277 Oct 2020 → Oct 2032 expected soft tissue sarcoma Institut Claudius Regaud Recruiting No outcome recorded
Phase 3 NCT04638790 Feb 2020 → Dec 2026 expected classic Hodgkin lymphoma State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia Recruiting No outcome recorded
Phase 3 NCT04221035 Nov 2019 → Nov 2026 expected neuroblastoma Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 3 NCT03805022 Feb 2019 → Dec 2026 expected soft tissue sarcoma Institut Bergonié Recruiting No outcome recorded
Phase 3 NCT03016819 Aug 2017 → Dec 2027 expected alveolar soft part sarcoma, leiomyosarcoma, synovial sarcoma Advenchen Laboratories, LLC Recruiting No outcome recorded
Phase 3 NCT03159897 Aug 2017 → Nov 2021 classic Hodgkin lymphoma Fondazione Italiana Linfomi - ETS Completed No outcome recorded
Phase 3 NCT02661503 Jul 2016 → Dec 2022 classic Hodgkin lymphoma University of Cologne Unknown Met primary
Phase 43 trials
Phase 4 NCT03500133 Oct 2017 → Oct 2027 expected Hodgkins lymphoma Hospital JP Garrahan Recruiting No outcome recorded
Phase 4 NCT00226473 Sep 2001 → Sep 2005 metastatic melanoma Dermatologic Cooperative Oncology Group Unknown No outcome recorded
Phase 4 NCT00188149 May 2000 → Dec 2007 Hodgkins lymphoma University Hospital Carl Gustav Carus Unknown No outcome recorded
Phase not applicable6 trials
— NCT01868451 May 2013 → Jun 2026 Hodgkins lymphoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
— NCT01578967 Apr 2012 → Aug 2016 Hodgkins lymphoma UNC Lineberger Comprehensive Cancer Center Completed No outcome recorded
— NCT00901303 Oct 2008 → Jun 2010 Hodgkins lymphoma Weill Medical College of Cornell University Terminated No outcome recorded Stop: Enrollment
— NCT00526318 Jan 2007 → Dec 2016 neuroblastoma German Society for Pediatric Oncology and Hematology GPOH gGmbH Unknown No outcome recorded
— NCT00070343 Aug 2003 → ? cutaneous melanoma Jonsson Comprehensive Cancer Center Unknown No outcome recorded
— NCT00416377 — lymphoma Children's Cancer and Leukaemia Group Unknown No outcome recorded
Comparator or background therapy91 trials
Phase 1 NCT03761095 Background Mar 2019 → Feb 2024 leiomyosarcoma PTC Therapeutics Completed No outcome recorded
Phase 1 NCT01056679 Background Apr 2010 → Apr 2014 Hodgkins lymphoma University of Cologne Completed No outcome recorded
Phase 1 NCT01060904 Background Jan 2010 → Sep 2012 Hodgkins lymphoma Seagen Inc. Completed No outcome recorded
Phase 1 NCT00796991 Comparator Feb → Nov 2009 melanoma Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT00498979 Background May 2007 → May 2010 melanoma Case Comprehensive Cancer Center Completed No outcome recorded

News releases announcing trial results or a regulatory action · 17

DateIssuerRelease
2026-06-01 Bristol-Myers Squibb Regulatory Bristol Myers Squibb Announces Opdivo® (nivolumab) in Combination with AVD Receives Expanded EU Label with Approval in Frontline Advanced Classical Hodgkin Lymphoma bms.com ↗
This approval marks a significant milestone, establishing the Opdivo plus AVD combination as the first immunotherapy-based regimen available in the European Union (EU) for newly diagnosed advanced cHL.
2026-03-20 Bristol-Myers Squibb Regulatory Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. and EMA Approvals for Opdivo® (nivolumab) bms.com ↗
The U.S. Food and Drug Administration (FDA) granted approval of Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL.
2025-12-11 Bristol-Myers Squibb Regulatory U.S. Food and Drug Administration (FDA) Grants Priority Review to Bristol Myers Squibb's Application for Opdivo® (nivolumab) Plus Chemotherapy Combination for Classical Hodgkin Lymphoma bms.com ↗
2024-12-05 Pfizer Results Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS pfizer.com ↗
In addition, updated two-year follow-up data from a Phase 2 study investigating the combination of ADCETRIS, nivolumab, doxorubicin, and dacarbazine in newly diagnosed early-stage classical Hodgkin lymphoma (cHL) will be presented highlighting promising efficacy and safety of this investigational novel combination.
2024-06-01 Pfizer Results Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma pfizer.com ↗
The four-year analysis presented by the GHSG showed superior progression-free survival (PFS) and improved tolerability for patients compared to a current standard of care regimen used in Europe in this setting.
2022-06-03 PTC Therapeutics Results Preliminary Results Presented at ASCO Demonstrated Promising Clinical Efficacy with Unesbulin in Leiomyosarcoma Study ptcbio.com ↗
The results from the dose escalation study which evaluated unesbulin in combination with dacarbazine (DTIC), will be presented on Saturday, June 4, during the Sarcoma Oral Abstract Session beginning at 1:15 p.m. CDT at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
2022-05-26 Takeda Results Takeda and Seagen to Highlight ADCETRIS ® Combination Data Showing Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma takeda.com ↗
These results clearly show that the addition of brentuximab vedotin to chemotherapy improves the long-term outcome of patients and the combination should be considered a standard of care.
2020-11-05 Takeda Results Takeda Oncology Demonstrates Leadership in Hematologic Cancers at 62nd American Society of Hematology (ASH) Annual Meeting takeda.com ↗
Brentuximab Vedotin with Chemotherapy for Patients with Previously Untreated, Stage III/IV Classical Hodgkin Lymphoma: 5-Year Update of the ECHELON-1 Study.
2016-08-01 Eisai Inc. Results EISAI PRESENTS RESULTS OF ADDITIONAL ANALYSIS OF PHASE Ⅲ STUDY OF ANTICANCER AGENT HALAVEN® AT 14TH JSMO ANNUAL MEETING PLENARY SESSION eisai.com ↗
According to the results of these analyses, eribulin demonstrated a trend for extension in overall survival over dacarbazine in each subtype.
2015-11-18 Bristol-Myers Squibb Results New Long-Term Data on Opdivo and the Opdivo + Yervoy Regimen Shows Survival Benefit Across Lines of Therapy in Advanced Melanoma bms.com ↗
In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine.
2015-07-22 AstraZeneca Results AstraZeneca provides update on selumetinib in uveal melanoma astrazeneca.com ↗
Wednesday, 22 July 2015 AstraZeneca today announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival.
2015-05-30 Eisai Inc. Results ANTICANCER AGENT HALAVEN® SHOWS SIGNIFICANT EXTENSION IN OVERALL SURVIVAL IN PHASE Ⅲ STUDY ON SOFT TISSUE SARCOMA Phase Ⅲ data to be presented in a Soft Tissue Sarcoma oral session at ASCO eisai.com ↗
In the study's primary endpoint of overall survival (OS), eribulin demonstrated a statistically significant extension in OS over the comparator treatment dacarbazine (eribulin median OS: 13.5 months vs dacarbazine median OS: 11.5 months, Hazard Ratio (HR) 0.768 [95% CI=0.618-0.954], p=0.017).

All press releases naming this drug 17 releases

DateIssuerRelease

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 230 sources stand behind the page.

FieldValueCited text
Known as Dacarbazine “The "alkylating-based" group will receive CapTem regimen (capecitabine and temozolomide, /4 week), alternatively LV5FU2 (folinic acid-5 fluorouracil)-dacarbazine (1x/2 week) or...” NCT03217097 ↗
220

“Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide,...” NCT03500133 ↗

“Patients received trametinib (2 mg orally) once daily or intravenous dacarbazine (1000 mg per square meter of body-surface area) or paclitaxel (175 mg per square meter) every 3 weeks.” PMID 22663011 ↗ Jun 2012

“Dacarbazine administered at 1000 mg/m2 by intravenous infusion (IVI), over 90±15 minutes on Day 1 every 21 days until tumor progression or unacceptable toxicity occurs;” NCT02049905 ↗

“A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma” NCT00327600 ↗

“The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments.” NCT00797472 ↗

“ABVD was given every 28 days (doxorubicin 25 mg/m2, bleomycin 10 mg/m2, vinblastine 6 mg/m2, and dacarbazine 375 mg/m2 intravenously on days 1 and 15)” PMID 30658935 ↗ Jan 2019

“A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma” NCT00542893 ↗

“Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle.” NCT02275598 ↗

“Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)” NCT04307277 ↗

“BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine” NCT00188149 ↗

Show 210 more sources

Known as Biocarbazine r ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as dacarbacine “Chemotherapy with dacarbacine (DTIC) is widely accepted as the standard treatment in metastatic melanoma” NCT00779714 ↗
Known as Dacarbasine ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as Dacarbazina ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as Dacarbazine (DTIC)-Dome “Dacarbazine (DTIC)-Dome” NCT01133977 ↗
Known as Dacarbazine - DTIC “Dacarbazine - DTIC” NCT07275216 ↗
2

“Dacarbazine - DTIC” NCT01835145 ↗

“Dacarbazine - DTIC” NCT00089544 ↗

Known as Dacarbazinum ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as Dacin (Dacarbazin).ATC-Code: L01AX04 “Dacin (Dacarbazin).ATC-Code: L01AX04” NCT00794235 ↗
Known as Decarbazine ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as Dicarbazine ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as DTIC “A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha...” NCT00911443 ↗
24

“Dacarbazine Dosage: 1,000 mg/m2 DTIC every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or for a maximum of 8 cycles, whichever occurs first.” NCT01055522 ↗

“A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma” NCT00327600 ↗

“This is a combination Phase I/II design that explores the toxicity and activity of a combination of sunitinib and Dacarbazine (DTIC) for metastatic melanoma.” NCT00496223 ↗

“Phase II Study of Interleukin-21 (rIL-21) vs Dacarbazine (DTIC) in Patients With Metastatic or Recurrent Melanoma” NCT01152788 ↗

“Dacarbazine (DTIC): 375 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.” NCT03033914 ↗

“Chemotherapy with dacarbacine (DTIC) is widely accepted as the standard treatment in metastatic melanoma” NCT00779714 ↗

“Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients” NCT00553618 ↗

“Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s” NCT00308607 ↗

“Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s” NCT00813449 ↗

“Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks” NCT01227889 ↗

Show 14 more sources

Known as DTIC (Dacarbazine) “DTIC (Dacarbazine)” NCT00597038 ↗
Known as DTIC-Dome “DTIC-Dome (Dacarbazine)” NCT00354523 ↗
Known as NCI C04717 ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Known as NSC-45388 ChEMBL registry synonym — accepted as the source's own label CHEMBL476 ↗
Action Inhibit “Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells” NCT00654732 ↗
Modality Small molecule — CHEMBL476 ↗
Route Intravenous “Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15 (ABVD).” NCT00002561 ↗