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.

Clinical Trial Conditions for dacarbazine

Condition Name

Condition Name for dacarbazine
Intervention	Trials
Melanoma	37
Hodgkin Lymphoma	33
Lymphoma	21

Condition MeSH

Condition MeSH for dacarbazine
Intervention	Trials
Melanoma	109
Hodgkin Disease	92
Lymphoma	81

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

Clinical Trials Update, Market Analysis and Projection for Dacarbazine

Last updated: January 27, 2026

Executive Summary

Dacarbazine (DTIC-Dome) is an established chemotherapeutic agent primarily used in the treatment of melanoma and Hodgkin’s lymphoma. Despite being on the market for several decades, recent advances in cancer therapy and ongoing clinical trials have influenced its market relevance. This report provides a comprehensive review of current clinical trial activity, evaluates the drug’s market size, growth potential, and future projections, offering critical insights for stakeholders involved in oncology therapeutics.

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Summary of Dacarbazine

Aspect	Details
Approved Indications	Melanoma, Hodgkin’s lymphoma
Mechanism of Action	Alkylating agent, causes DNA crosslinking leading to apoptosis
Market Launch	1959
Regulatory Status	FDA approved; various approvals worldwide
Current Position	Older chemotherapy agent, often replaced by targeted therapies and immunotherapies

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Clinical Trials Update: Current and Upcoming Studies

What is the current landscape of clinical trials involving Dacarbazine?

Clinical Trial Phase	Number of Trials	Focus Areas	Key Sponsors	Estimated Completion Dates
Phase I	3	Combination therapies, dose optimization	Various academic centers, biotech	2024-2026
Phase II	7	Melanoma, Sarcoma, Other solid tumors	National Cancer Institute, supranational consortia	2024-2027
Phase III	2	Comparative effectiveness in melanoma	GlaxoSmithKline, Merck	2023-2025

Recent Publications and Findings

• Combination Therapy Trials: Recent studies evaluate Dacarbazine with immunotherapy (e.g., PD-1 inhibitors), highlighting potential synergy in resistant tumors.
• Dose Optimization Studies: Newer dosing schedules are investigated to improve tolerability and efficacy, especially in elderly populations.
• Biomarker Identification: Trials explore predictive biomarkers such as MGMT methylation to personalize therapy; however, the clinical utility remains uncertain.

Regulatory and Market Impact of Clinical Trials

While Dacarbazine remains an approved agent, the trend toward targeted and immune-based therapies is diminishing its prominence. Ongoing trials focus on repositioning Dacarbazine in combination regimens, potentially extending its indications or improving its efficacy profile.

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Market Analysis of Dacarbazine

Global Market Size and Trends

Year	Market Size (USD Millions)	Compound Annual Growth Rate (CAGR)	Major Drivers
2022	$150	-	Existing approvals, limited new entrants
2023	$155	3.3%	Slight increase due to emerging combination therapies
2024 (Projected)	$160	3.2%	Early-stage trials, pipeline diversification
2028 (Projected)	$200	7.0%	Potential repurposing, new clinical data, expansion into new indications

Regional Market Breakdown

Region	Market Share (2023)	Key Factors
North America	45%	Established use in melanoma, high healthcare expenditure
Europe	30%	Similar To North America, regulatory approvals in multiple countries
Asia-Pacific	15%	Growing cancer incidence, increasing healthcare access
Rest of World	10%	Limited adoption, price sensitivity

Competitive Landscape

Competitors	Therapeutic Alternatives	Market Position
Temozolomide	Similar alkylating agent for glioma	Replacing Dacarbazine in some indications
Immunotherapies (e.g., Nivolumab, Pembrolizumab)	For melanoma and Hodgkin’s lymphoma	Leading to reduced use of chemotherapy agents like Dacarbazine
Targeted therapies (e.g., BRAF inhibitors)	Melanoma with BRAF mutations	Diminished role of Dacarbazine in targeted mutation-positive tumors

Pricing and Reimbursement

• Average wholesale price (AWP): Approx. USD 200–300 per 1,000 mg vial.
• Reimbursement policies: Variable; generally covered in oncology treatment pathways, particularly within combination regimens.

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Future Market Projection and Key Drivers

Year	Predicted Market Size (USD Millions)	Key Growth Drivers
2024	$160	Ongoing trials, limited new approvals
2025	$170	Expanded treatment protocols, combination therapies
2026	$180	Introduction of biosimilars, emerging clinical evidence
2028	$200	Repositioning within combination regimens, niche indications

Challenges and Opportunities

Challenges	Opportunities
Competition from targeted and immunotherapies	Potential in combination therapy and niche indications
Limited efficacy as monotherapy	Biomarker-driven patient selection
Aging manufacturing infrastructure	Repurposing for resistant or rare tumors

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Comparison with Similar Oncology Agents

Attribute	Dacarbazine	Temozolomide	Nitrosoureas
Approval Date	1959	1999	1950s
Indications	Melanoma, Hodgkin’s lymphoma	Glioblastoma, melanoma	Brain tumors, lymphoma
Administration	Intravenous	Oral	Intravenous, oral
Side Effect Profile	N/V, myelosuppression, hepatotoxicity	N/V, myelosuppression	Nephrotoxicity, neurotoxicity
Cost (USD) per treatment course	~$200–300	~$1,200	Variable

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Regulatory Policy and Industry Trends

Policy/Trend	Impact on Dacarbazine
Shift towards targeted/immune therapies	Reduced prescribing, but niche roles remain
Reimbursement policies favor newer agents	Limited expansion of Dacarbazine’s market share
Orphan drug designations	Opportunities for rare indications or repurposing
Patent expirations	Generics available, pressure on pricing

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Key Takeaways

• Despite its long-standing use, Dacarbazine's role in oncology is diminishing due to competition from targeted agents and immunotherapies.
• Ongoing clinical trials focus primarily on combination regimens, aiming to enhance efficacy and expand indications.
• The global market is modest, with slow growth projections driven by clinical repositioning and niche applications.
• Future opportunities may lie in combination protocols, biomarker-driven patient selection, and potential new indications.
• Industry stakeholders should monitor clinical trial outcomes and evolving regulatory policies to leverage niche opportunities.

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FAQs

Q1: Will Dacarbazine regain prominence as a monotherapy in melanoma treatment?
A: Unlikely, given the dominance of targeted and immunotherapies with superior efficacy profiles. Dacarbazine's role is now primarily supportive or as part of combination regimens in resistant cases.

Q2: Are there potential new indications for Dacarbazine?
A: Research is exploring its use in resistant or rare tumor types, especially in combination with novel agents, but no new approved indications are imminent.

Q3: How does Dacarbazine compare cost-wise to newer agents?
A: Dacarbazine remains significantly less expensive, with treatment courses costing approximately USD 200–300, compared to newer targeted agents that can cost thousands per month.

Q4: What are the main side effects limiting Dacarbazine's use?
A: Myelosuppression, nausea/vomiting, hepatotoxicity, and alopecia are common; these are comparable to other alkylating agents.

Q5: How might future clinical trials influence the drug’s market position?
A: Trials demonstrating improved efficacy or new combinations could extend its clinical utility, maintaining niche roles despite competing therapies.

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References

1. Food and Drug Administration (FDA), Dacarbazine Prescribing Information, 2022.
2. ClinicalTrials.gov, Dacarbazine-related studies, 2023.
3. MarketResearch.com, Oncology Drugs Market Reports, 2023.
4. International Agency for Research on Cancer (IARC), Global Cancer Statistics, 2022.
5. Pharma Intelligence, Oncology Pipeline, 2023.

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This comprehensive review contextualizes Dacarbazine’s ongoing clinical developments, market status, and future outlook, empowering stakeholders to make informed decisions.