TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer

NCT04475016 | Completed Phase 2 DMC

• 1 other identifier: B2020-103-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with nimotuzumab \& triprilimab as neoadjuvant treatment in locally advanced penile cancer.

Conditions

Penile Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathologically Complete Response

  Histopathologic assessment for patients undergoing surgical resection followed by 4 cycles of neoadjuvant treatment. Pathologically complete response is defined as the absence of noninvasive tumor residuals in inguinal lymph node and pelvic lymph node after neoadjuvant chemotherapy as assessed by American Joint Committee on Cancer (AJCC) staging version 8.0.

  12 weeks

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  6 weeks

• Progression Free Survival (PFS)

  2 months

• Overall Survival (OS)

  6 months

• Adverse events

  2-months

Study Arms (1)

Neoadjuvant Therapy

EXPERIMENTAL

TIP (Paclitaxel + Ifosfamide + Cisplatin) \& Nimotuzumab \& Triprilimab

Drug: Albumin-Bound Paclitaxel; Drug: Ifosfamide; Drug: Cisplatin; Drug: Nimotuzumab; Drug: Triprilimab

Interventions

Albumin-Bound Paclitaxel DRUG

260 mg/m² IV over 30 minutes on Day 1

Neoadjuvant Therapy

Ifosfamide DRUG

1200 mg/m² IV over 2 hours on Days 1-3

Neoadjuvant Therapy

Cisplatin DRUG

25 mg/m² IV over 2 hours on Days 1-3

Neoadjuvant Therapy

Nimotuzumab DRUG

400 mg IV on Day 1

Neoadjuvant Therapy

Triprilimab DRUG

240 mg IV on Day 1

Neoadjuvant Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Squamous cell carcinoma confirmed by histology or cytology;
• Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3);
• No prior chemotherapy for newly diagnosed or relapsed patients;
• There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1;
• the Eastern Cooperative Oncology Group (ECOG) scored 0-2;
• Blood marrow function: Hemoglobin(Hb) \>/= 80g/L; White blood cell count \>/= 3.0x10\^9/L; Neutrophil count \>/= 1.5x10\^9/L; Platelet count \>/= 100x10\^9/L;
• Liver function: AST, ALT, ALP \</= 2.5 ULN; Total bilirubin \</= 1.5 ULN;
• Estimated survival \>/= 12 months;
• No prior serious disease history of systemic organ;
• The participant unterstand this study procedure and sign the informed consent.

You may not qualify if:

• Peripheral neuropathy degree \>/=2 (affecting patient's function);
• Previously received any other experimental drug treatment within 4 weeks before enrollment;
• Patients with other cancer at present, or have other malignent tumor history within past 5 years. Except for: (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score\<6, PSA\<0.5ng/ml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years;
• Other serious or poorly controlled concomitant diseases, including but not limited to: (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood ,endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Penile Neoplasms

Interventions

Albumin-Bound Paclitaxel; Ifosfamide; Cisplatin; nimotuzumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: August 12, 2020
• Primary Completion: May 6, 2022
• Study Completion: May 30, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

CN (1)