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NCT Number: NCT05835804

Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.

Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.

The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carboplatin Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nivolumab Paclitaxel Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location contact

Alexandre COUTTE, MD

SUB_INVESTIGATOR

Aline HOUESSINON, MD

CONTACT

[email protected]

03 22 45 54 99

Antoine GALMICHE, PR

SUB_INVESTIGATOR

Aurelie BIET, MD

SUB_INVESTIGATOR

Aurelie MOREIRA, MD

SUB_INVESTIGATOR

Bernard DEVAUCHELLE, Pr

SUB_INVESTIGATOR

Bruno CHAUFFERT, Pr

SUB_INVESTIGATOR

Cyril PAGE, Pr

SUB_INVESTIGATOR

Jean Marc CONSTANS, Pr

SUB_INVESTIGATOR

Jérémie BETTONI, MD

SUB_INVESTIGATOR

Michel LEFRANC, Pr

SUB_INVESTIGATOR

Stéphanie DAKPE, Pr

SUB_INVESTIGATOR

Sylvie TESTELIN, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

WHO status : 0, 1 or 2.
Age > 18ans
Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
Possible location of the tumour by clinical examination, CT-scan
Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
Neutrophils > 1000/mm3.
Platelets > 100 000/mm3.
Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
Prothrombin rate > 70 %.
Social insurance
Informed consent

Exclusion criteria

WHO status : 0, 1 or 2.
Age > 18ans
Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
Possible location of the tumour by clinical examination, CT-scan
Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
Neutrophils > 1000/mm3.
Platelets > 100 000/mm3.
Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
Prothrombin rate > 70 %.
Social insurance
Informed consent

Treatment and study plan

GCP intratumoral catheter

Drug

After local anaesthesia, intratumoral catheter will be place (one or several depending tumour criteria).The catheter placement could be guided by radiological imaging. Gemcitabine (200mg/l), carboplatin (100mg/l) and paclitaxel (20mg/l) will be each diluted in each in 160ml of NaCl0.9%. GCP will be administered successively for 8hours, at 20ml/h with a total duration of 24hours. The ITC will be done every 28 days for 6 times maximum in case of good response and tolerance. Nivolumab 240 mg IV will be started 1 to 7 days before the first intratumoral infusion and every 15 days, until progression or 2 until years in case of partial response, complete response or stabilization. Evaluation of tumour size will be done by CT-scan, or MRI 2every 2 months and PET-FDG every 3 months.

Primary outcomes

local response rate according to RECIST criteria

Time frame: 3 years
RECIST is a standard way to measure the response of a tumor to treatment. The criteria to determine whether a tumor disappears, shrinks, are complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Evaluation of target lesions
- Complete Response (CR): Disappearance of all target lesions
- Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
- Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Evaluation of non-target lesions
- Complete Response (CR): Disappearance of all non-target lesions and no

Study contacts

Contact information is provided by the study sponsor or research team.

Aline HOUESSINON, MD

CONTACT

[email protected]

03 22 45 54 99

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: NIVOCHIMLOC

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Apr 28, 2023
Registry last updated: Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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