A study to see whether adding a low-dose immunotherapy drug (nivolumab) to standard chemotherapy works better and is safe compared to chemotherapy alone in patients with high-risk cancer of the penis.

An Open-label, Randomized, Superiority Trial Evaluating the Efficacy and Safety of Perioperative Low-dose Nivolumab Plus Taxane, Ifosfamide, and Platinum (TIP) versus TIP Alone in Patients with High-risk Penile Squamous Cell Carcinoma (TIP-NIVO) - TIP-NIVO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108742

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C609- Malignant neoplasm of penis, unspecified

Interventions

Intervention1: Nivolumab plus TIP regimen: Nivolumab 20mg 3-weekly plus TIP for 4 cycles Paclitaxel 175mg per m2 - IV infusion- D1 Ifosfamide 1200mg per m2 - IV infusion- D1-D3 Cisplatin 25mg per m2

Eligibility

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed squamous cell carcinoma of penis 2) High-risk nodal disease (cN2 and N3) 3) Bilateral inguinal lymph node involvement 4) Multiple inguinal lymph nodes involved (unilateral or bilateral) a)Fixed inguinal lymph node(s) b)Pelvic lymph node involvement (unilateral or bilateral) c)ECOG performance status 0 2 d) Adequate organ function 5) No prior systemic therapy for penile cancer 6) No active autoimmune disease requiring systemic treatment

Exclusion criteria

Exclusion criteria: 1) HIV, Active Hepatitis B or C 2) Concurrent malignancy 3) Uncontrolled Diabetes Mellitus, Hypertension 4) Use of systemic immunosuppressive (Prednisolone greater than 10mg/day)

Design outcomes

Primary

Measure	Time frame
disease free survivalTimepoint: one year	—

Secondary

Measure	Time frame
overall survival(OR) Surgical Resectability Rate objective response rate (ORR) Safety and Tolerability Duration of Response Timepoint: one year	—

Countries

India

Contacts

Public ContactDr Aditya Dhanawat

Advanced Centre for Treatment Research and Education in Cancer (ACTREC),

adi.dhanawat@gmail.com09040040900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026