CLINICAL TRIALS PROFILE FOR DACARBAZINE

505(b)(2) Clinical Trials for DACARBAZINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT05068453 ↗	Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis	Not yet recruiting	Beijing Cancer Hospital	Phase 1	2021-10-01	Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.
New Combination	NCT05070221 ↗	Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis	Not yet recruiting	Beijing Cancer Hospital	Phase 1	2021-10-01	Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

All Clinical Trials for DACARBAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	Amgen	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00000626 ↗	Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.
NCT00002561 ↗	Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease	Completed	Eastern Cooperative Oncology Group	Phase 3	1994-01-25	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.
NCT00002561 ↗	Radiation Therapy and Chemotherapy in Treating Patients With Hodgkin's Disease	Completed	NCIC Clinical Trials Group	Phase 3	1994-01-25	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease.

Clinical Trial Conditions for DACARBAZINE

Condition Name

Condition Name for DACARBAZINE
Intervention	Trials
Melanoma	37
Hodgkin Lymphoma	33
Lymphoma	21
Malignant Melanoma	13

Condition MeSH

Condition MeSH for DACARBAZINE
Intervention	Trials
Melanoma	109
Hodgkin Disease	92
Lymphoma	81
Sarcoma	18

Clinical Trial Locations for DACARBAZINE

Trials by Country

Trials by Country for DACARBAZINE
Location	Trials
Canada	135
United Kingdom	102
Italy	101
Germany	101
Australia	86

Trials by US State

Trials by US State for DACARBAZINE
Location	Trials
California	72
New York	59
Texas	58
Florida	49
Pennsylvania	49

Clinical Trial Progress for DACARBAZINE

Clinical Trial Phase

Clinical Trial Phase for DACARBAZINE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	12

Clinical Trial Status

Clinical Trial Status for DACARBAZINE
Clinical Trial Phase	Trials
Completed	106
Recruiting	56
Active, not recruiting	32

Clinical Trial Sponsors for DACARBAZINE

Sponsor Name

Sponsor Name for DACARBAZINE
Sponsor	Trials
National Cancer Institute (NCI)	34
Bristol-Myers Squibb	15
Seagen Inc.	13

Sponsor Type

Sponsor Type for DACARBAZINE
Sponsor	Trials
Other	263
Industry	163
NIH	36

Dacarbazine Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

Dacarbazine is an oncology alkylating agent used primarily for metastatic melanoma and Hodgkin lymphoma. The clinical-trial landscape is active at the level of combination regimens and real-world or comparative practice studies rather than broad, stand-alone phase-3 development. Market conditions remain anchored by long-established, off-patent use in major regions, with pricing and availability driven by supply, generic competition, and oncology formularies rather than new patent-protected pipeline expansion.

What is the current clinical-trials picture for dacarbazine?

Trial activity mix

Dacarbazine trials in recent years are dominated by:

• Combination regimens with immune checkpoint inhibitors, targeted agents, or established chemotherapy backbones.
• Studies focused on regimen optimization, dosing schedules, response outcomes, and safety in specific patient subgroups.
• Evidence-generation efforts tied to standard-of-care updates and practice patterns rather than new molecular-entity development.

Typical endpoints used in dacarbazine studies

Most contemporary studies measuring outcomes with dacarbazine use endpoints common across hematologic malignancies and melanoma trials:

• Objective response rate and duration of response
• Progression-free survival and overall survival
• Toxicity profiles, with particular attention to myelosuppression, nausea/vomiting, and hepatic effects
• Treatment delivery metrics (dose intensity, discontinuation rates)

Where dacarbazine remains the anchor drug

Dacarbazine continues to be embedded in protocols where historical response benefit and regimen familiarity drive clinician adoption:

• Metastatic melanoma regimens (often in combination contexts)
• Hodgkin lymphoma settings in combination chemotherapy backbones
• Regional and institutional protocols where dacarbazine availability and cost matter

What is the regulatory and labeling context shaping trial use?

Core positioning

Dacarbazine’s practical deployment is constrained by approved indications and established administration practices:

• It is used in chemotherapy protocols for specific cancers rather than as a broad-spectrum oncology platform drug.
• Trial designs therefore tend to test combinations and sequencing rather than replacing dacarbazine with alternative alkylators.

Practical implication for development

Because dacarbazine is off-patent in major jurisdictions, new development efforts are likely to focus on:

• Responder subgroups and regimen selection
• Real-world outcomes
• Translational biomarkers supporting combination strategies

How big is the dacarbazine market and what drives it?

Demand drivers

Dacarbazine demand is driven by:

• Incidence and treatment volumes in melanoma and Hodgkin lymphoma
• Treatment-line patterns and clinician preference for established regimens
• Generic availability and tender-driven procurement
• Hospital formulary decisions based on procurement cost, supply reliability, and administration convenience

Supply and pricing structure

Dacarbazine’s market economics are shaped by:

• Generic penetration in the U.S. and EU
• Occasional manufacturing disruptions (typical for sterile injectables) affecting short-term pricing and allocation
• Contract pricing dynamics for hospital procurement

Market size framing (directional)

Because dacarbazine is a mature, off-patent injectable, market sizing generally tracks:

• Global oncology chemotherapy volumes in the specific segments using dacarbazine
• Share of patients receiving alkylator-containing protocols for melanoma and Hodgkin lymphoma

A defensible way to model demand is to start with treated population estimates in labeled indications, then apply:

• Uptake rate of dacarbazine-containing regimens by line of therapy
• Relative share versus competing chemo backbones and newer immuno-oncology options

How will dacarbazine perform versus alternative oncology regimens?

Competition set

Dacarbazine competes in practice with:

• Newer melanoma regimens built around immune checkpoint inhibitors and targeted therapies
• Alternate alkylating or cytotoxic backbones in lymphoma protocols
• Combination regimens where dacarbazine is either a component or replaced by other agents depending on country-specific formularies and guideline adoption

Competitive reality

Even with immuno-oncology expanding melanoma care, dacarbazine persists because:

• It remains embedded in selected treatment pathways and combination contexts
• Its cost profile can favor its continued use in budget-constrained systems
• Local availability and tender outcomes can keep dacarbazine in routine chemotherapy protocols

Market projection: what is the growth outlook for dacarbazine?

Base-case projection logic (mature/off-patent injectable)

For off-patent sterile injectables, the usual projection pattern is:

• Low to moderate demand growth tied to population and oncology volume growth
• Flat or declining net revenue in price terms due to generic competition
• Revenue stability depending on supply consistency and tender economics

Revenue drivers vs headwinds

Drivers

• Steady incidence-driven use in melanoma and Hodgkin lymphoma
• Continued guideline inclusion in specific regimens and combinations
• Hospital procurement stability when supply is reliable

Headwinds

• Shift to immuno-oncology and targeted regimens in melanoma reducing chemo reliance
• Generic price compression over time
• Regulatory and quality-driven manufacturing constraints affecting supply
• Potential substitution by other cytotoxics with better procurement economics

Projection directional call

• Unit volumes: likely to remain steady to slightly growing in line with oncology-treated populations.
• Net revenue (value): likely to be flat to declining in many markets as generic competition maintains price pressure.

Where do clinical-trial outcomes matter most for market outlook?

Clinical-trial outcomes for dacarbazine primarily matter through:

• Reinforcement of combination regimens where dacarbazine continues to show response benefit
• Evidence for sequencing or toxicity mitigation that improves treatment adherence
• Data that support reimbursement and guideline acceptance in specific settings

For mature drugs, trial impact is usually more about confirming use-case viability than changing the molecule’s adoption curve.

What is the investment and R&D implication?

If you sponsor or invest in dacarbazine-related development

The opportunity is typically in:

• Combination regimen strategy with measurable clinical endpoints
• Formulation or delivery improvements that reduce administration burden or toxicity management complexity
• Comparative effectiveness in specific patient groups where dacarbazine still shows practical value

If you are assessing commercial exposure

The key diligence points are:

• Manufacturing and supply reliability risk (sterile injectable constraints)
• Contract pricing and tender cycles
• Channel dynamics in hospital procurement
• Competitive intensity from additional generic entrants

Key Takeaways

• Dacarbazine’s clinical-trial activity centers on combination regimens and evidence generation for established use cases, especially in melanoma and Hodgkin lymphoma.
• The market is mature and off-patent, with demand anchored by oncology volumes and regimen inclusion rather than new protected launches.
• Net revenue outlook is likely flat to declining in price terms due to generic competition, while unit volumes should remain steady to slightly up.
• Trial outcomes matter mainly for maintaining or expanding specific combination use and supporting guideline and reimbursement decisions in targeted contexts.

FAQs

1. Is dacarbazine still used in first-line settings?
   Use depends on country guideline versions and regimen selection by cancer subtype and patient profile, with more frequent positioning in chemo-backbone contexts than as a standalone modern regimen.

2. What drives clinician use of dacarbazine today?
   Protocol familiarity, combination utility in selected indications, and procurement economics in hospital formularies.

3. Do dacarbazine trials focus on new mechanisms?
   Most current activity focuses on combinations and regimen optimization rather than new mechanism-of-action development.

4. What is the biggest commercial risk for dacarbazine?
   Price compression from generic competition plus supply reliability constraints typical of sterile injectables.

5. Does immuno-oncology reduce dacarbazine demand?
   It can reduce reliance on older chemotherapy backbones in melanoma, but dacarbazine remains used in defined pathways and combinations where clinicians still see value.

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References

[1] FDA. Dacarbazine prescribing information (product labeling, including indications and administration guidance). U.S. Food and Drug Administration.
[2] EMA. Dacarbazine product information and European SmPC entries (indications, safety profile, and administration). European Medicines Agency.
[3] National Cancer Institute (NCI). Dacarbazine drug information and cancer-related references. National Institutes of Health.
[4] clinicaltrials.gov. Search results for dacarbazine interventional studies (study types, phases, endpoints, and recruitment status). U.S. National Library of Medicine.