Back to resultsTIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
Primary Purpose
Penile Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin-Bound Paclitaxel
Ifosfamide
Cisplatin
Nimotuzumab
Triprilimab
Sponsored by
About this trial
This is an interventional treatment trial for Penile Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant Therapy
Arm Description
TIP (Paclitaxel + Ifosfamide + Cisplatin) & Nimotuzumab & Triprilimab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Progression Free Survival (PFS)
Progression free survival is defined as the time from the randomization to tumor progression or death due to any cause.
Overall Survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Adverse events
Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04475016
Brief Title
TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
Official Title
A Single Center and Single Arm Study of TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Penile cancer is a rare malignant tumor, which often occurs in the inner plate of prepuce and glans. Squamous cell carcinoma is the most common pathological type. Lymph node metastasis is a crucial factor that leads to poor prognosis of penile cancer. The 5-year OS of penile cancer patients without lymph node metastasis is 90%. Still, it goes down sharply in patients with inguinal lymph node metastasis and pelvic lymph node metastasis, which is 50% and 0%, respectively.
Using neoadjuvant chemotherapy to treat patients with locally advanced penile cancer (T4, any N stage, or any T stage, N3) may improve their prognosis. TIP (Paclitaxel + Ifosfamide + Cisplatin) regimen is the first line neoadjuvant treatment recommended by NCCN guidelines. Epidermal growth factor receptor (EGFR) plays a vital role in the development of penile cancer. It's also an important therapeutic target for penile cancer. PD-1 is an immune checkpoint molecule on the surface of T cells. In recent years, immune-checkpoint inhibitors targeting PD-1 have shown good efficacy in a variety of tumors. Some phase II / III clinical trials have shown that PD-1 inhibitors can improve the prognosis of patients with lung squamous cell carcinoma, head and neck squamous cell carcinoma and cervical cancer. Previous studies have found that PD-L1 is highly expressed in 40% - 60% of penile cancer, suggesting that penile cancer patients may benefit from immunotherapy.
The management of penile cancer with lymph node metastasis is difficult, especially for N2-3 stage. This phase II study aim to explore an effective combination therapy for locally advanced penile cancer. 29 patients need to be enrolled.TIP & nimotuzumab & triprilimab will be administered per 21-day until surgery, evidence of disease progression or onset of unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant Therapy
Arm Type
Experimental
Arm Description
TIP (Paclitaxel + Ifosfamide + Cisplatin) & Nimotuzumab & Triprilimab
Intervention Type
Drug
Intervention Name(s)
Albumin-Bound Paclitaxel
Intervention Description
260 mg/m² IV over 30 minutes on Day 1
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
1200 mg/m² IV over 2 hours on Days 1-3
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
25 mg/m² IV over 2 hours on Days 1-3
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
400 mg IV on Day 1
Intervention Type
Drug
Intervention Name(s)
Triprilimab
Intervention Description
240 mg IV on Day 1
Primary Outcome Measure Information:
Title
Percentage of Participants With Pathologically Complete Response
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame
6 weeks
Title
Progression Free Survival (PFS)
Description
Progression free survival is defined as the time from the randomization to tumor progression or death due to any cause.
Time Frame
2 months
Title
Overall Survival (OS)
Description
Overall survival is defined as the time from randomization to death due to any cause.
Time Frame
6 months
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
Time Frame
2-months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
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