Chemotherapy drug for Post-Anti-PD-1 Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post-Anti-PD-1 Melanoma+7 MoreChemotherapy drug - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, TransCon IL-2 β/γ, to treat various solid tumors. The trial will test how well the drug works and what side effects it may have.

Eligible Conditions
  • Post-Anti-PD-1 Melanoma
  • Non-Small Cell Lung Cancer
  • Platinum-resistant Ovarian Cancer
  • Neoadjuvant Melanoma
  • Two-Lobe Plus Cervical Cancer
  • Advanced Solid Tumors
  • Locally Advanced Solid Tumors
  • Solid Metastatic Tumor

Treatment Effectiveness

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: 2 years

12 months
Recommended Phase 2 Dose (RP2D)
15 weeks
Major Pathologic Response
Pathologic Complete Response
2 years
Event free survival (EFS) by RECIST 1.1
Average of 2 years
Duration of Response
Overall Response Rate
Overall Survival (OS)
PK Characterization (AUC0-t)
PK Characterization (AUClast)
PK Characterization (Cmax)
PK Characterization (Tmax)
PK Characterization (t1/2)
Progression Free Survival (PFS)
Day 21
Maximum Tolerated Dose (MTD)
Year 1
Time to Response
Year 2
Safety and Tolerability

Trial Safety

Trial Design

11 Treatment Groups

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist...
1 of 11
Part 3 Dose Expansion: TransCon IL-2 β/γ with SOC Chemotherapy
1 of 11
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
1 of 11
Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery
1 of 11
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed...
1 of 11
Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
1 of 11
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonis...
1 of 11
Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
1 of 11
Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo ...
1 of 11
Part 2 Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
1 of 11
Part 1 Dose Escalation: TransCon IL-2 β/γ
1 of 11

Experimental Treatment

317 Total Participants · 11 Treatment Groups

Primary Treatment: Chemotherapy drug · No Placebo Group · Phase 1 & 2

Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgeryExperimental Group · 3 Interventions: TransCon TLR7/8 Agonist, Surgery, TransCon IL-2 β/γ · Intervention Types: Drug, Procedure, Drug
Part 3 Dose Expansion: TransCon IL-2 β/γ with SOC ChemotherapyExperimental Group · 2 Interventions: TransCon IL-2 β/γ, Chemotherapy drug · Intervention Types: Drug, Drug
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC ChemoExperimental Group · 2 Interventions: TransCon IL-2 β/γ, Chemotherapy drug · Intervention Types: Drug, Drug
Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgeryExperimental Group · 2 Interventions: Surgery, TransCon IL-2 β/γ · Intervention Types: Procedure, Drug
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgeryExperimental Group · 3 Interventions: Surgery, TransCon IL-2 β/γ, Pembrolizumab · Intervention Types: Procedure, Drug, Drug
Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
Drug
Experimental Group · 1 Intervention: TransCon IL-2 β/γ · Intervention Types: Drug
Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 AgonistExperimental Group · 2 Interventions: TransCon TLR7/8 Agonist, TransCon IL-2 β/γ · Intervention Types: Drug, Drug
Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with PembrolizumabExperimental Group · 2 Interventions: TransCon IL-2 β/γ, Pembrolizumab · Intervention Types: Drug, Drug
Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgeryExperimental Group · 4 Interventions: Surgery, TransCon IL-2 β/γ, Chemotherapy drug, Pembrolizumab · Intervention Types: Procedure, Drug, Drug, Drug
Part 2 Dose Escalation: TransCon IL-2 β/γ with PembrolizumabExperimental Group · 2 Interventions: TransCon IL-2 β/γ, Pembrolizumab · Intervention Types: Drug, Drug
Part 1 Dose Escalation: TransCon IL-2 β/γ
Drug
Experimental Group · 1 Intervention: TransCon IL-2 β/γ · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
1999
Completed Phase 3
~2060
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Ascendis Pharma Oncology Division A/SLead Sponsor
1 Previous Clinical Trials
220 Total Patients Enrolled
Ascendis Pharma A/SLead Sponsor
11 Previous Clinical Trials
1,144 Total Patients Enrolled
Davis Torrejon-CastroStudy DirectorAscendis Pharma Oncology Division A/S
Gil NyamuswaStudy DirectorAscendis Pharma Oncology Division A/S
1 Previous Clinical Trials
220 Total Patients Enrolled
Davis T CastroStudy DirectorAscendis Pharma Oncology Division A/S

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You are female and/or male and are sexually active.
You have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts.
You have not received any treatment for cancer in the past 30 days.
You have received an immunotherapy prior to C1D1 and you have no known immunologic or toxicities to C1D1.
You have a complete resectable tumor.