Large randomized study of thymosin alpha 1, interferon alfa, or both in combination with dacarbazine in patients with metastatic melanoma.

Maio M, Mackiewicz A, Testori A, Trefzer U, Ferraresi V, Jassem J, Garbe C, Lesimple T, Guillot B, Gascon P, Gilde K, Camerini R, Cognetti F

Journal of clinical oncology : official journal of the American Society of Clinical Oncology1 Mar 2010Cited by 54 (Europe PMC)

PMID20194853DOI10.1200/jco.2009.25.5208PepBankPUB-20194853

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metastatic melanoma, ten tumor responses occurred with DTIC plus interferon alfa plus thymosin alpha‑1 (3.2 mg), versus four in the control group.
In plain wordsIn metastatic melanoma, more tumors responded with thymosin alpha‑1 added to dacarbazine and interferon alfa than with dacarbazine and interferon alfa alone.
Peptide
Thymosin alpha-1
Outcome
IncreaseTumor responses (DTIC+IFN-alpha+Talpha1 3.2 mg)
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
3.2 mgAs given in this study (human).
Source sentences
Summary
Ten and 12 tumor responses were observed in the DTIC+IFN-alpha+Talpha1 (3.2 mg) and DTIC+Talpha1 (3.2 mg) groups, respectively, versus four in the control group, which was sufficient to reject the null hypothesis that P(0) < or = .05 (expected response rate of standard therapy) in these two arms.
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485301
02HumanRandomized controlled trialEfficacy outcome
In metastatic melanoma, 12 tumor responses occurred with DTIC plus thymosin alpha‑1 (3.2 mg), versus four in the control group.
In plain wordsIn metastatic melanoma, more tumors responded with dacarbazine plus thymosin alpha‑1 than with dacarbazine and interferon alfa.
Peptide
Thymosin alpha-1
Outcome
IncreaseTumor responses (DTIC+Talpha1 3.2 mg)
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
3.2 mgAs given in this study (human).
Measurements
Tumor responses
12 count
DTIC+Talpha1 3.2 mg
Source sentences
Summary
Ten and 12 tumor responses were observed in the DTIC+IFN-alpha+Talpha1 (3.2 mg) and DTIC+Talpha1 (3.2 mg) groups, respectively, versus four in the control group, which was sufficient to reject the null hypothesis that P(0) < or = .05 (expected response rate of standard therapy) in these two arms.
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485302
03HumanRandomized controlled trialEfficacy outcome
In metastatic melanoma, duration of response ranged from 1.9 to 23.2 months with thymosin alpha‑1 and from 4.4 to 8.4 months in the control group.
In plain wordsIn metastatic melanoma, responses lasted 1.9 to 23.2 months with thymosin alpha‑1 and 4.4 to 8.4 months in the control group.
Peptide
Thymosin alpha-1
Outcome
Not applicableDuration of response
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
1.6-6.4 mgAs given in this study (human).
Measurements
Duration of response
1.9 to 23.2 months
Talpha1
Duration of response
4.4 to 8.4 months
control
Source sentences
Summary
Duration of response ranged from 1.9 to 23.2 months in patients given Talpha1 and from 4.4 to 8.4 months in the control group.
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485303
04HumanRandomized controlled trialEfficacy outcome
In metastatic melanoma, median overall survival was 9.4 months with thymosin alpha‑1 and 6.6 months with control, a difference that was not statistically significant.
In plain wordsIn metastatic melanoma, people given thymosin alpha‑1 lived a median 9.4 months and controls 6.6 months, but the difference was not statistically significant.
Peptide
Thymosin alpha-1
Outcome
No significant changeMedian overall survival
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Analysis
Secondary
Outcome group
Mortality · Cancer
Studied dose
1.6-6.4 mgAs given in this study (human).
Measurements
Median OS
9.4 months
Talpha1
Median OS
6.6 months
control
Hazard ratio
0.8 HR
OS
Source sentences
Summary
Median OS was 9.4 months in patients given Talpha1 versus 6.6 months in the control group (hazard ratio = 0.80; 9% CI, 0.63 to 1.02; P = .08).
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485304
05HumanRandomized controlled trialEfficacy outcome
In metastatic melanoma, progression-free survival was longer with thymosin alpha‑1 than with control, but not statistically significant (P = .06).
In plain wordsIn metastatic melanoma, time without progression was longer with thymosin alpha‑1 than with control, but the difference was not statistically significant.
Peptide
Thymosin alpha-1
Outcome
No significant changeProgression-free survival
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
1.6-6.4 mgAs given in this study (human).
Measurements
Hazard ratio
0.8 HR
PFS
Source sentences
Summary
An increase in PFS was observed in patients given Talpha1 versus the control group (hazard ratio = 0.80; 95% CI, 0.63 to 1.01; P = .06).
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485305
06HumanRandomized controlled trialSafety outcome
In metastatic melanoma, adding thymosin alpha‑1 to DTIC and interferon alfa did not lead to additional toxicity.
In plain wordsIn metastatic melanoma, adding thymosin alpha‑1 to dacarbazine and interferon alfa did not cause extra toxicity.
Peptide
Thymosin alpha-1
Outcome
No significant changeAdditional toxicity
Study
n: not reported in source
Comparator
DTIC plus interferon alfa (control group)
Outcome group
Adverse events · Whole body
Studied dose
1.6-6.4 mgAs given in this study (human).
Source sentences
Summary
Addition of Talpha1 to DTIC and IFN-alpha did not lead to any additional toxicity.
1 context sentence(design, population, supporting numbers)
Summary · context
Four hundred eighty-eight patients were randomly assigned to five treatment groups: DTIC+IFN-alpha+Talpha1 (1.6 mg); DTIC+IFN-alpha+Talpha1 (3.2 mg); DTIC+IFN-alpha+Talpha1 (6.4 mg); DTIC+Talpha1 (3.2 mg); DTIC+IFN-alpha (control group).
Report a problemFND-2019485306

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Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · source ClinicalTrials.gov (opens in a new tab)

RecruitingPhase 2NCT07644897

Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma

Sun Yat-sen Universityn = 5530 May 2023 to est. 30 Sept 2027

Melanoma · Immune-related Adverse Event · Immune Checkpoint Inhibitor

Trial page ClinicalTrials.govUpdated 12 Jun 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:02 UTC
First added · source update from Europe PMC