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NCT04310397
Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
Phase 2 trial testing Dabrafenib in Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 in 4 participants. Terminated before completion.
9 October 2023
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 29 January 2020 |
| Primary completion | 9 October 2023 |
| Estimated completion | 9 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dabrafenib (dabrafenib) — full drug profile →
- Spartalizumab — full drug profile →
- Therapeutic Conventional Surgery
- Trametinib (trametinib) — full drug profile →
Conditions studied
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 — all drugs for Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 →
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 — all drugs for Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 →
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8 — all drugs for Pathologic Stage IIID Cutaneous Melanoma AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 or Pathologic Stage IIIC Cutaneous Melanoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | Arm 1 |
|---|---|---|
| Fever | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Soft Tissue Infection | Skin and subcutaneous tissue disorders | — |
Other adverse events (16 terms — click to expand)
| Reaction | System | Arm 1 |
|---|---|---|
| Chills | General disorders | — |
| Alanine aminotransfease increased | Investigations | — |
| Alkaline amionotransferase | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Elevated WBC | Blood and lymphatic system disorders | — |
| Increased ANC | Blood and lymphatic system disorders | — |
| Creatinine Increased | Investigations | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Blurred Vision | Eye disorders | — |
Most-reported serious reactions: Fever, Diarrhea, Soft Tissue Infection.
Data from ClinicalTrials.gov NCT04310397 adverse events section.
Sponsor's own description
This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. Patients who achieve a pathologic complete response after 8 weeks of neoadjuvant dabrafenib and trametinib will receive adjuvant dabrafenib and trametinib. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dabrafenib, trametinib, and spartalizumab may help to control melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunomodulatory Effects of BRAF, MEK, and CDK4/6 Inhibitors: Implications for Combining Targeted Therapy and Immune Checkpoint Blockade for the Treatment of Melanoma.
Lelliott EJ, McArthur GA, Oliaro J, Sheppard KE. · · 2021 · cited 46× · PMID 34025662 · DOI 10.3389/fimmu.2021.661737 -
Onco-immunomodulatory properties of pharmacological interference with RAS-RAF-MEK-ERK pathway hyperactivation.
Avery TY, Köhler N, Zeiser R, Brummer T, et al · · 2022 · cited 31× · PMID 35965494 · DOI 10.3389/fonc.2022.931774 -
The future of targeted kinase inhibitors in melanoma.
Caksa S, Baqai U, Aplin AE. · · 2022 · cited 25× · PMID 35513054 · DOI 10.1016/j.pharmthera.2022.108200 -
Advances in targeted therapy and immunotherapy for melanoma (Review).
Qin Z, Zheng M. · · 2023 · cited 20× · PMID 37559935 · DOI 10.3892/etm.2023.12115 -
Thinking Small: Small Molecules as Potential Synergistic Adjuncts to Checkpoint Inhibition in Melanoma.
Chacon AC, Melucci AD, Qin SS, Prieto PA. · · 2021 · cited 9× · PMID 33810078 · DOI 10.3390/ijms22063228 -
"To Anticipate": Neoadjuvant Therapy in Melanoma with a Focus on Predictive Biomarkers.
Garutti M, Buriolla S, Bertoli E, Vitale MG, et al · · 2020 · cited 4× · PMID 32708968 · DOI 10.3390/cancers12071941 -
Top advances of the year: Melanoma.
Augustin RC, Luke JJ. · · 2023 · cited 3× · PMID 36629350 · DOI 10.1002/cncr.34590 -
Melanoma update: is a cure now in sight?
Liaqat S, Khattak MA. · · 2025 · cited 1× · PMID 40536073 · DOI 10.1111/imj.70085
Verify or expand the search:
- PubMed search for NCT04310397
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
Currently open trials in the same condition.
- NCT05176470 — Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients · Phase 1 · active not recruiting
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- NCT04708418 — A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients · Phase 2 · active not recruiting
- NCT04940299 — Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial · Phase 2 · active not recruiting
- NCT05039801 — IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors · Phase 1 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04310397 (US National Library of Medicine, public domain)
- 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 M.D. Anderson Cancer Center
- Last refreshed: 30 October 2024
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/NCT04310397.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing